FDA Adverse Event Malfunction Summary report: N

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

MDR report key: 3892863 · Received June 24, 2014

Report

Report Number: 3015876-2014-00699
Event Type: Malfunction
Date Received: June 24, 2014
Date of Event: May 15, 2014
Report Date: May 29, 2014
Manufacturer: PHYSIO-CONTROL, INC
Product Code: LDD
PMA / PMN Number: K063119
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO THEN REPLACED BOTH THE SYSTEM CONTROLLER (SC) PCB AND USER INTERFACE (UI) PCB ASSEMBLIES AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED SC PCB ASSEMBLY WHERE IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U61. THE IC CHIP PUT THE UNIT INTO A CONSTANT RESET CONDITION, WHICH WOULD NOT ALLOW THE DEVICE TO COMPLETE THE BOOT UP CYCLE AND PREVENTED DEFIBRILLATION FROM BEING DELIVERED. THE REMOVED UI PCB ASSEMBLY WAS AN ANCILLARY PART AND THERE WAS NO FAILURE OF THIS ASSEMBLY.

Description of Event or Problem · 1

THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT IT WOULD NOT COMPLETE THE BOOT UP CYCLE AND, AS A RESULT, WOULD NOT BE ABLE TO PROVIDE THERAPY, IF NECESSARY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
369249	LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR	DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)	LDD	PHYSIO-CONTROL, INC	20

Patients

Seq	Age	Sex	Outcome	Treatment
1