Device Recall Welch Allyn PIC 50 의 리콜

Recall

35688

Class 1

Z-1195-06

2006-06-30

2006-07-08

Terminated

United States

2007-11-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46623

The welch allyn pic 50 defibrillators may display a 'defib comm' or 'pace comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ecg and deliver the appropriate therapy.

MRL sent Urgent Medical Device Recall letters dated 6/30/06 via certified mail to the direct accounts informing them of an intermittent connection between a pin and socket on a circuit board inside of the device that could result in a malfunction that prevents or unacceptably delays the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units' parts/serial numbers and requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. The accounts were also instructed to respond to the notification within 5 working days if the unit has displayed the Defib Comm error, and within 30 days if it has not displayed the Defib Comm error by fax or mail. A loaner PIC 50 will then be sent to the consignee with instructions on how to return their unit for correction.