FDA Adverse Event Malfunction Summary report: N

LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

MDR report key: 1964208 · Received December 22, 2010

Report

Report Number: 3015876-2010-01412
Event Type: Malfunction
Date Received: December 22, 2010
Date of Event: November 29, 2010
Report Date: December 2, 2010
Manufacturer: PHYSIO-CONTROL, INC
Product Code: MKJ
PMA / PMN Number: K991910
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE THERAPY CABLE CONNECTOR AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

Description of Event or Problem · 1

IT WAS REPORTED DURING A CARDIAC ARREST CALL, THAT THE EMS CREW CONNECTED THEIR DEVICE TO THE PT WITH THE HARD PADDLES AND THE DEVICE SHOWED A VENTRICULAR FIBRILLATION RHYTHM. THE CREW THEN ATTEMPTED TO DELIVER A SHOCK TO THE PT; HOWEVER, THE DEVICE WOULD NOT DELIVER THE ENERGY. THE CREW THEN TRIED TO REMOVE AND RECONNECT THE THERAPY CABLE TWICE, AND AFTER THE SECOND TIME THE DEVICE WAS THEN ABLE TO DELIVER THERAPY. THE CREW THEN SHOCKED THE PT ONE TIME AT 360 JOULES. AFTER THE SUCCESSFUL DELIVERY OF ENERGY, THE DEVICE EXPERIENCED THE SAME FAILURE AGAIN. THE EMS CREW THEN IMMEDIATELY CONNECTED THEIR BACK UP DEVICE TO THE PT AND WAS ABLE TO SUCCESSFULLY CONTINUE PT CARE. THEY REPORTED THAT THE BACK UP DEVICE DELIVERED TWO SHOCKS SUCCESSFULLY AND THE PT WAS THEN PACED UNTIL THEY REACHED THE HOSPITAL . THERE WAS NO REPORT THAT THE PT SUFFERED ANY ADVERSE EFFECT FROM THE REPORTED FAILURE AND WAS TRANSPORTED TO THE LOCAL HOSPITAL WITH A PULSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES		MKJ	PHYSIO-CONTROL, INC	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR