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– Randy Bullard, President/CEO

January 2010: vol. 19:01

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

Recall – Firm Press Release: Cardiac Science AED – Voluntary Medical Device Correction

November 13, 2009: Cardiac Science Corporation issued a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device's periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, and CardioVive 92531, 92532, and 92533 devices.

Cardiac Science has received a total of 64 complaints concerning four resistors within certain AED s. Two of these complaints were associated with a failure to deliver therapy. The company has also received 114 complaints regarding “Service Required” messages resulting from a specific relay switch failure. There have been no reported instances where this issue has resulted in an inability to deliver therapy.

Until a correction is available in May 2010, the company strongly advises customers to check the status indicator on the front of the AED and follow the procedures documented in the materials accompanying the AED. In the interim, the company advises customers to keep their AED s in service and follow the normal testing and maintenance procedures in the Operator and Service Manual. A copy of these procedures is available at www.cardiascience.com/AED175. If the AED is not rescue ready (the indicator is red) customers should contact the company immediately at 425.402.2000(option 1). Customers can also email the company at AED175@cardiascience.com.

Medical Device Recall – Company Release: Arizant Healthcare Inc: – Power Cord Recall

Arizant Healthcare Inc. has initiated a nationwide voluntary recall of 100/110-volt power cords attached to its temperature management units and pressure infusion power pack. The affected cords are manufactured by Electri-Cord Manufacturing Corporation of Westfield, Pennsylvania The recall is in response to a small number of customer complaints of melting, smoking or fire within the power cord plug. Multiple medical device manufacturers have recently reported power cord concerns to the FDA. The affected power cords may crack and fail at/inside the plug.

The cords are attached to Arizant products manufactured between March 2005 and October 2009. The affected products include specific units within Bair Paws, Bair Hugger, and Ranger platforms. The cords may in use with: Bair Paws 850 and 875 warming units, Bair Hugger 500/OR, 505, 750, and 775 warming units, Ranger 245 and 247 warming units, and Ranger Pressure Infusion Power Packs. All reports to date have involved Electri-Cord Manufacturing Corporation's AC power cords with a black plastic bridge. Arizant will provide replacement power cords for all its temperature management units that include cords with this bridge design; however, replacing damaged/worn cords will be the first priority. Power cords that do not have a black bridge are not affected by this recall.

Users should examine their units and notify the Arizant website (www.arizant.com/powercords) regardless of whether damaged cords are found or not. Arizant will contact the facility to arrange replacement cords or answer any questions. Customers can also reach Arizant at 877-947-1487, Monday-Friday, 7:30 am to 4:30 PM (CST).

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DRAEGER MEDICAL, INC: Manufacturer: Draeger Medical Systems, Inc., Danvers, Massachusetts. Monitors: Delta/Delta XL Monitors with Omega S package. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated November 2009. Volume in Commerce: 4,188 units. Reason: Monitor is rebooting/resetting. FDA recall #Z-0582-2010. FDA Enforcement Report, 01/06/10.

GE MEDICAL SYSTEMS, LLC, Waukesha. CT Systems Tables: 1) Model # 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi, 2) Model # 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi, 3) Model # 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi. Class II. Firm initiated recall is ongoing. Firm notified users by visit beginning April 27, 2010. Volume in Commerce: 1,179 units. Reason: Failure to provide the certification label required by 21 CFR 1010.2. FDA recalls #Z-1257/1259-2001. FDA Enforcement Report, 12/30/09.

GE MEDICAL SYSTEMS, LLC, Waukesha, Wisconsin: Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Innova Bi-Plane Cardiovascular Systems: Innova 2121-1Q/3131-1Q (Biplane). Class II. Firm initiated recall is ongoing. Firm notified users by letter dated October 14, 2009. Volume in Commerce: 114 units. Reason: Switch failure may impact patient safety. The failure could occur due to collision between the lateral plan of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no injury has been reported related to this condition. FDA recall #Z-0540-2010. FDA Enforcement Report, 01/06/10.

HILL-ROM, INC., Batesville, Indiana. Birthing Beds: Affinity Four, Model P3700B. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated November 16, 2009. Volume in Commerce: 2,551 units in U.S. (additional 4,171 OUS). Reason: The brakes may not hold or lock. FDA recall #Z-0548-2010. FDA Enforcement Report, 01/06/10.

IMAGING SCIENCES INTERNATIONAL, LLC, Hatfield, Pennsylvania. Dental X-Ray: i-Cat Classic, 3D Dental Imaging System. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated October 30, 2009. Volume in Commerce: 98 units. Reason: Overhead carriage drops quickly. FDA recall #Z-0543-2010. FDA Enforcement Report, 01/06/10.

MAQUET, INC., Wayne, New Jersey: Manufacturer: Maquet Critical Care AB, Solna, Sweden. Ventilators: 1) Servo 300/300A (SV300) Siemens – Elema AB; 2) Servo SV900C/D/E (SV900) Siemens – Elema AB. Class II. Firm initiated recall is ongoing. Firm notified users by letter beginning November 17, 2009 and ending November 23, 2009. Volume in Commerce: SV300 - 7,847 units, SV900 - 8,428 units. Reason: Some Servo Ventilators 300/300A and Servo Ventilators 900C/D/E should not be used with a system that may generate negative pressure below 100cm H2O (closed system suctioning) due to the risk of damaging the ventilator's pressure transducers. FDA recalls #Z-0588/0589-2010. FDA Enforcement Report, 01/06/10.

MEDTRONIC SOFAMOR DANEK USA, INC. – Dallas Distribution, Fort Worth, Texas. Midas Rex Legend Footed Attachment: AF01 for use with all Legend and Legend EHS motors. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated November 30, 2009. Volume in Commerce: 64 units. Reason: Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use. FDA recall #Z-0546-2010. FDA Enforcement Report, 01/06/10.

ZOLL MEDICAL CORPORATION, World Wide Headquarters, Chelmsford, Massachusetts. Zoll R Series Defibrillator/Pacemaker/Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 31, 2009 and on September 1 2009. Volume in Commerce: 247 units. Reason: Failure of device to display ECG could delay delivery of defibrillation or pacing therapy. FDA recall #Z-2315-2009. FDA Enforcement Report, 12/30/09.