FDA Announces Recall of Certain Welch Allyn Automated External Defibrillators
Posted by
Staff WriterJuly 31, 2006 6:39 PMThe US Food and Drug Administration (FDA) and MRL, Inc (a Welch Allyn company), recently notified healthcare professionals about the class 1 recall of 1184 automated external defibrillators ([AEDs] Welch Allyn PIC 50, catalog #97108X) manufactured during February 2002 to October 2004; 673 units were sold within the United States.
The recall occured because of an electrical contact problem that may result in the device's failure to provide a defibrillation shock, leading to delay or failure of resuscitative efforts. According to the recent alert from the FDA's safety information and adverse event reporting program the device malfunction may be accompanied by various error messages (eg, "Defib Comm") on the display panel.
To date, 18 cases of device malfunction have been reported, corresponding to 1.5% of the recalled devices; patient resuscitation was delayed in 2 instances. The company noted that many Defib Comm errors are transient, and most are detected by an automatic self-test upon unit start-up. To eliminate the risk for resuscitation failure, devices that display the error message should be serviced before further use.
Free loaner devices are being made available for use during servicing of malfunctioning units. All costs associated with shipping, handling, and replacement of the units' "DEFIB" board will also be covered by the company. Additional information concerning the recall may be obtained by contacting the company at 1-800-462-0777 or 1-847-520-0300.