FDA Adverse Event Death Summary report: N

LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

MDR report key: 2413705 · Received January 12, 2012

Report

Report Number: 3015876-2012-00030
Event Type: Death
Date Received: January 12, 2012
Date of Event: December 29, 2011
Report Date: December 30, 2011
Manufacturer: PHYSIO-CONTROL, INC
Product Code: MKJ
PMA / PMN Number: K082937
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: EMERGENCY MEDICAL TECHNICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE DUE TO THE THERAPY CONNECTOR WIRE HARNESS ASSEMBLY (W11) RIBBON CABLE CONNECTOR (P23) WHICH WAS NOT CONNECTED TO THE MATING CONNECTOR (J23) ON THE THERAPY PCB ASSEMBLY. THE RIBBON CABLE ASSEMBLY WAS RECONNECTED TO THE THERAPY PCB ASSEMBLY AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE. THERE WERE NO DISCREPANCIES OBSERVED WITH EITHER THE RIBBON CABLE CONNECTOR OR THE MATING CONNECTOR ON THE THERAPY PCB ASSEMBLY. THE CONCLUSIVE CAUSE OF WHY THE HARNESS WAS NOT CONNECTED PROPERLY COULD NOT BE DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PATIENT EVENT, THE DEVICE WOULD NOT RECOGNIZE A CONNECTION TO THE PATIENT WITH THE QUIK-COMBO THERAPY CABLE ASSEMBLY. THE CUSTOMER TRIED TO CONNECT TWO ADDITIONAL SETS OF DEFIBRILLATION ELECTRODES DURING THE EVENT, BUT THE DEVICE WAS STILL UNABLE TO DETECT A CONNECTION. THE PATIENT DID NOT SURVIVE THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR	DEFIBRILLATORS, AUTOMATIC, EXTERNAL	MKJ	PHYSIO-CONTROL, INC	15

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Death