FDA Adverse Event Malfunction Summary report: N

LIFEPAK CR(R) PLUS DEFIBRILLATOR

MDR report key: 6161244 · Received December 9, 2016

Report

Report Number: 3015876-2016-01514
Event Type: Malfunction
Date Received: December 9, 2016
Date of Event: October 26, 2016
Report Date: December 9, 2016
Manufacturer: PHYSIO-CONTROL, INC
Product Code: MKJ
PMA / PMN Number: K033275
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THAT THE NEGATIVE TABS CONNECTING HLC BATTERY DESIGNATOR BT3 TO THE ANALOG PCB ASSEMBLY HAD BROKEN OF THE PCB. THIS EVIDENCE SUGGESTED THAT THE DEVICE MAY HAVE BEEN DROPPED. THE DEVICE WOULD CHARGE AND SHOCK DURING TESTING BECAUSE BT3 STILL MAINTAINED AN INTERMITTENT CONNECTION. THIS ALSO RESULTED IN HLC BATTERIES BT1 AND BT2 DEPLETING FASTER THAN NORMAL. PHYSIO-CONTROL EXAMINED THE ELECTRONIC RECORDS FROM THE DEVICE AND OBSERVED THAT THE INTERNAL HLC BATTERIES HAD DROPPED TO ZERO CAPACITY IN SEPTEMBER 2016. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD DISPLAYED A PREMATURE LOW-BATTERY INDICATOR. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES HAD DROPPED TO ZERO (0) VOLTS. THE HLC BATTERIES DROPPING TO ZERO (0) VOLTS COULD INHIBIT THE DEVICE'S ABILITY TO PROVIDE DEFIBRILLATION THERAPY, IF NECESSARY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
813250	LIFEPAK CR(R) PLUS DEFIBRILLATOR	DEFIBRILLATORS, AUTOMATIC, EXTERNAL	MKJ	PHYSIO-CONTROL, INC	CRPLUS

Patients

Seq	Age	Sex	Outcome	Treatment
1