The FDA notified healthcare professionals last week of a Class I recall of LifePak 15 monitor/defibrillators manufactured between March 26 and December 15, 2009 (see: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209467.htm).
There is potential for the device to power on or off by itself, sometimes not allowing the operator to turn the unit back on or off again. A company spokesman told Fire Engineering that the recall affected some 3,609 units, of which 14 had reported failures, none affecting patient care. A circuit board in the LP-15 was apparently able to contact Styrofoam material, at times resulting in a short circuit condition. Immediately on identifying the issue, Physio Control voluntarily and immediately contacted affected customers to initiate repairs. One month later, following review of the situation, the FDA classified the situation as a Class I recall. In a Physio Control press release, CEO Brian Webster attributed discovery of the problem to the revamping of Quality Control Systems.
“Physio Control’s complete overhaul of both the manufacturing and quality control systems has been refreshing to watch,” Fire Engineering EMS Editor Mike McEvoy noted. “Early discovery of problems which are sure to occur with any product or device is the hallmark of an effective quality assurance program.”