FDA Adverse Event Malfunction Summary report: N

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

MDR report key: 3010663 · Received March 19, 2013

Report

Report Number: 3015876-2013-00211
Event Type: Malfunction
Date Received: March 19, 2013
Date of Event: February 19, 2013
Report Date: February 19, 2013
Manufacturer: PHYSIO-CONTROL, INC
Product Code: LDD
PMA / PMN Number: K063119
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PHYSIO REPLACED THE SYSTEM CONTROLLER PCB AND USER INTERFACE PCB ASSEMBLIES AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM CONTROLLER PCB AND USER INTERFACE PCB ASSEMBLIES AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE FAILURE TO BE DUE TO THE SYSTEM CONTROLLER PCB ASSEMBLY; HOWEVER FURTHER COMPONENT CAUSE COULD NOT BE DETERMINED.

Additional Manufacturer Narrative · 1

(B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

Description of Event or Problem · 1

THIS FAILURE WAS REPORTED UNDER MEDWATCH REPORT NUMBER 3015876-2013-00110. THE ISSUE WAS THOUGHT TO BE RESOLVED; HOWEVER IT APPEARS TO BE AN INTERMITTENT FAILURE. IT WAS AGAIN REPORTED THAT THE DEVICE FAILED TO BOOT-UP COMPLETELY AND WOULD STOP AT THE POWER ON SELF TEST. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
114333	LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR	DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)	LDD	PHYSIO-CONTROL, INC	20

Patients

Seq	Age	Sex	Outcome	Treatment
1