April 23, 2010 (Rockville, Maryland) — The Food and Drug Administration has issued a class 1 recall of the LIFEPAK 15 Monitor/Defibrillator (Physio-Control, Redmond, WA) [1]. The recall affects devices manufactured and distributed between March 26, 2009 and December 15, 2009.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. With the LIFEPAK monitor/defibrillator, there is potential for the device to power off and on by itself, to power off and not turn back on again, to turn off and require the operator to turn it back on, or to stay powered on and not allow itself to power off.

"Our internal analysis has verified that for those monitor/defibrillators an internal component could inadvertently contact the power printed-circuit board assembly (PCBA)," the company stated on its website. Physicians can determine if devices are affected by the recall by serial number, which is located on the underside of the device.

In September, as reported by heartwire , the FDA issued another class 1 recall of the LIFEPAK CR Plus automated external defibrillators. With those devices, a humid environment was thought to cause the devices to improperly analyze the heart rhythm, resulting in a delay or failure to deliver therapy. In June 2005, the FDA issued a warning letter to Medtronic describing persistent problems with the cable connectors and wiring on the company's LifePak 12 external cardiac defibrillators. Medtronic has partnered with Physio-Control since 1998 to manufacture and distribute these devices.

The FDA said healthcare professionals should report adverse events or side effects related to the LIFEPAK 15 monitor/defibrillator to the MedWatch Safety Information and Adverse Event Reporting Program.

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