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A summary of FDA recalls, safety alerts, and manufacturer field corrective actions as reported for the third quarter of the year. This information is a snapshot and chronology of the reported events. For additional details refer to the cited volume of original publication or contact the Home Office.
AMD LASERS, L.L.C., Laser: Picasso/Picasso Lite Lasers for Dentistry. Class II. Reason: Product is noncompliant with the Federal laser product performance standard in certain requirements. The ON/OFF key on some of the lasers could be removed with force while the key was in the ON position. Vol. 19:13.
BIOSITE, INC. Triage Profiler Controls. Class II. Reason: Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field. Vol. 19:11.
CARDIAC SCIENCE CORPORATION. Defibrillator: Automated External Defibrillators. Class I. Update Reason: Certain Models of Powerheart G3 AED’s may not have received adequate electrical safety testing prior to being shipped from the factory. Vol. 19:12.
CARDIAC SCIENCE CORPORATION. Defibrillators: Powerheart 9390A AED. Class II. Reason: The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy. Vol. 19:10.
CARDIAC SCIENCE CORPORATION. Treadmills: Models TM55, TM65, and CR60. (Brand names include Quinton, Burdick, and Cardiac Science). Class II. Reason: As safety testing may not have allowed for complete evaluation of the electrical isolation of the treadmill, there is a remote chance a shock hazard could exist. Vol. 19:10.
DATASCOPE CORPORATION. Balloon Pump IABP. Class II. Reason: Certain IABPs have the potential to experience display related issues that may cause the user to be unable to view the IABP on the information screen. Vol. 19:10.
GE HEALTHCARE, LLC. Monitor: Carescape TM Monitor B850. Class II. Reason: Four safety issues: 1) Loss of user input when using certain displays or the USB remote control; 2) Potential for a delay in treatment or missed alarm when the alarm light is used as a primary alarm source and audible alarms are turned down or off; 3) Will not use user entered hemoglobin values when calculating SvO values, which could result in incorrect treatment of a patient; 4) When used in conjunction with Tram, the HR Alarm Limits may revert back to default settings which could result in a missed alarm. There were no reported patient injuries or illnesses. Vol. 19:13.
GE HEALTHCARE, LLC. Radiology Innova Systems. Class II. Reason: GE Healthcare has become aware of a potential loss of gantry and table motions that affect the listed systems and may impact patient safety. Vol. 19:11.
HAAG-STREIT USA, INC. Slit-Lamp: Lenstar LS 900, Biomicroscope. Class II. Reason: During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect intra-ocular lens (IOL). Vol. 19:11.
HOSPIRA, INC. Accessory Power Pack. Class II. Reason: The Power Pack Accessory is not certified to UL 60601 standard or Subject 1363A for relocatable power taps intended for use with medical equipment. Potential problems could include electrical shock, electrical short, or electrical fire. Vol. 19:13.
HOSPIRA, INC. Infusers: a) Symbiq One-Channel Infuser b) Symbiq Two-Channel Infuser. Class I. Reason: Hospira has received numerous customer complaints of the Symbiq Infusion pump’s failure to detect air-in-line conditions during operation. Vol. 19:10.
HOSPIRA, INC. Infuser: Symbiq One and Two Channel Infuser. Class I. Reason: If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result. Vol. 19:13.
IKARIA HOLDINGS. INOMAX DS Drug Delivery System. Class I. Reason: The pressure switch in the IOMAX DS drug delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation of patients. Vol. 19:12.
INVACARE CORP. Hospital Bed. Class II. Reason: Invacare Corporation issued a device correction in October 2006 for the IVC Bed Foot Actuator used on the IVC Bed series. The actuators were not in the fully extended position and could not be mounted onto the beds. All affected consignees were notified of this correction in October 2006. Vol. 19:13.
INVACARE CORP. Hospital Bed Mattresses. Class II. Reason: These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric, and electric beds and associated bed rails do not meet some of the requirements of the voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment as intended. Use of these particular mattresses in combination with Invacare beds and bed rails may put the users at increased risk of entrapment. Vol. 19:13.
MALLINCKRODT, INC. Hydradjust IV DR Urological Table Generator. Class II. Reason: Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative. Vol. 19:11.
MEDTRONIC CARDIOVASCULAR REVASCULARIZATION & SURGICAL THERAPY. Hospital Grade Power Cord: detachable unit, supplied with Medtronic Bio-Console 550, 560, Medtronic autoLog, and Medtronic Sequestra 1000 since 2003. Class II. Reason: The power cord’s prongs may crack and fall at/or inside the plug. Vol. 19:10.
MINDRAY DS USA, INC., dba Datascope Patient Monitoring. Passport V Monitor. Class II. Reason: An issue has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational. Vol. 19:12.
MINNTECH CORPORATION. DSD Application Guide: for the Pentax Universal Video Scope Hookup only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U. Class II. Reason: The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. Vol. 19:12.
PHILIPS HEALTHCARE INC. AC Power Cords. Class II. Reason: Power cords’ prongs may crack or fail – Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Co power cords used with medical devices may be defective in that the power cord’s prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock. Vol. 19:12.
PHILIPS MEDICAL SYSTEMS. Defibrillator – AED. Class II. Reason: Seventeen AEDs failed production line testing (Final Acceptance Testing). Vol. 19:11.
NOVA BIOMEDICAL CORPORATION. Nova StatStrip Glucose Test Strips. Class II. Reason: Glucose strips report low glucose results. Vol. 19:12.
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. X-Ray: 1) DigitalDiagnost General Radiology; 2) BuckyDiagnost General Radiology and Tomo, 3) EasyDiagnost Multi-functional R/F Systems. Class II. Reason: Device failed to display appropriate labels indicating Radiation Symbol along with the required wording. Vol. 19:12.
PHYSIO-CONTROL, INC. Defibrillator/Monitor:LIFEPAK 15. Class I. Update. Reason: Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn’t turn off. Vol. 19:12.
PHYSIO-CONTROL, INC. Defibrillator/Monitor: LIFEPAK 20/20e. Class I. Reason: A failure on the power supply assembly can result in either “No DC power” or “No DC or AC power”. A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate. Vol. 19:10.
PHYSIO-CONTROL, INC . Defibrillator Paddles. Class II. Reason: Sterilization efficacy could not be confirmed for sterilization methods on External Sterilization Paddles and Pediatric attachments. Vol. 19:13.
RESPIRONICS, INC. Ventilator: Trilogy 100 Ventilator. Class II. Reason: It is possible that the battery could electrically short, resulting in a potential fire or a thermal event. Vol. 19:11.
ROMEDIC, INC. Battery Charger: for EVA 450 Patient Lift. Class II. Reason: Incorrect battery chargers were supplied with the EVA 450 Patient Lifts. Charger unit stops working and will not charge it. New chargers supplied to customers. Vol. 19:10.
SIEMENS HEALTHCARE DIAGNOSTICS, INC. IMMULITE 2000/2500 Chemiluminescent Substrate Module. Class II. Reason: Some substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods. Vol. 19:11.
SIEMENS MEDICAL SOLUTIONS, USA, INC. X-Ray: Axiom Artis System with Motor Controller Unit, intended for x-ray, angiographic use. Class II. Reason: Sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts might increase during the lifetime of the system. Vol. 19:12.
SIEMENS MEDICAL SOLUTIONS, USA, INC. X-Ray: Axiom Artis MP/Artis dMP and Artis zee Multipurpose Angiographic X-ray System. Class II. Reason: If the Multipurpose C-arm gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion. Vol. 19:13.
SMITHS MEDICAL ASD, INC. Medfusion Syringe Infusion Pump: Models 3010 and 3010a with Software versions 2.0.2., 2.0.3, and 2.0.4. Class II. Reason: Pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has not received reports of serious patient injury or death. Vol. 19:12.
SONOSITE, INC. Sonosite TEE, 8-3 MHz Transducer. Class II. Reason: The TEE transesophageal transducer, when connected to a Sonosite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array. Vol. 19:12.
SPINEMATRIX, INC. Lumbar Matrix Scan Diagnostic Electromyography System. Class II. Reason: The design audit in July 2009 revealed numerous design verification tests that either did not pass or did not meet the design input requirement, including the possibility of a physician reviewing one patient’s scan without realizing that it was actually from a different patient. Vol. 19:11.
STERIS CORPORATION. Surgical Table: Model # 4085, 5085 & 5085SRT. Class II. Reason: A limited quantity of the manifold assemblies were manufactured with incorrect washers and springs in the valves of the manifold. This error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table sections move slowly or drift without prompting by an operator. Vol. 19:10.
STRYKER ENDOSCOPY. Crossfire Console. Class II. Reason: RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot Switch. Vol. 19:12.
STRYKER INSTRUMENTS DIVISION OF STRYKER CORP. Bur Guard: intended for use with the Impaction Drill. Replace by dates of May 2009 through August 2009. Class II. Reason: The inner diameter of the Bur Guards may be out of specification. If there is excess material on the inside of the Bur Guard at the location where the guard tapers, it may come into contact with the Nose Cone of the drill. This could result in an injury or burn to the patient and/or user. Vol. 19:13.
STRYKER MEDICAL DIVISION OF STRYKER CORP. Stretchers With Crank. Class II. Reason: The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the thread on the brass nut, and the screw and the nut can become mis-aligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inoperable over time with the excessive wear of the brass nut. This may delay care for a patient who requires the fowler to be raised. Vol. 19:13.
TELEFLEX MEDICAL. Hudson RCI AQUA+ Flex Hygroscopic Condenser Humidifier. Class I. Reason: The patient end of the 22 cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector and therefore disconnect from the endotracheal tube. A disconnect in ventilator dependent patients without prompt response to the alarm could lead to hypoxia, organ failure, or cardio-arrest. Vol. 19:12.
ZIMMER, INC. Screwdriver: Abbott Spine PathFinder, Cannulated Poly Screwdriver II. Class II. Reason: The screw driver may fracture, resulting in surgical delays and/or fragments going into the surgical area. Vol. 19:13.
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FDA News Release: July 13, 2010
FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall: Company must provide transition guide for facilities using Colleague infusion pumps. The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination. Vol. 19:10.
FDA Posting 7/20/10: CONSTELLATION Vision System: Recall
Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System
Recall Class: Class I: Date Recall Initiated: April 30, 2010
Product: CONSTELLATION Vision System; Use: The Alcon CONSTELLATION Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various types of eye surgery.
FDA Comments: On July 2, 2010, Alcon sent its customers an "Urgent Medical Device Recall" letter to all its CONSTELLATION users. The letter informed customers about the potential problem and stated that Alcon representatives will visit ALL U.S. facilities to update the software, replace the touchscreen circuit board, and to answer any questions. This recall will not require the removal of the CONSTELLATION Vision System from any healthcare facility. Vol. 19:11.