FDA Adverse Event Malfunction Summary report: N

LIFEPAK CR(R) PLUS DEFIBRILLATOR

MDR report key: 4251968 · Received November 14, 2014

Report

Report Number: 3015876-2014-01363
Event Type: Malfunction
Date Received: November 14, 2014
Date of Event: October 22, 2014
Report Date: October 22, 2014
Manufacturer: PHYSIO-CONTROL, INC
Product Code: MKJ
PMA / PMN Number: K033275
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): 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.

Additional Manufacturer Narrative · 1

PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO VERIFY THE REPORTED ISSUE OF ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) BEING PRESENT ON THE DISPLAY. THE READINESS INDICATOR ON THE DISPLAY SHOWED "OK" WHEN RECEIVED, INDICATING THE DEVICE WAS READY FOR USE, AND THE DEVICE WOULD POWER ON AND DEFIBRILLATE WHEN PROMPTED. THERE WAS ALSO NO EVIDENCE IN THE DEVICE'S MEMORY THAT THE THREE ICONS HAD EVER BEEN PRESENT. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. 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 ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON THE DISPLAY. THE THREE ICONS BEING ILLUMINATED INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
738125	LIFEPAK CR(R) PLUS DEFIBRILLATOR	DEFIBRILLATORS, AUTOMATIC, EXTERNAL	MKJ	PHYSIO-CONTROL, INC	CRPLUS

Patients

Seq	Age	Sex	Outcome	Treatment
1