BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 5429566 · Received February 10, 2016

    Report

    Report Number
    3015876-2016-00139
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    January 21, 2016
    Report Date
    February 10, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. 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 OBSERVED THAT THE KEPS NUT FOR THE POSITIVE BATTERY CONTACT WAS LOOSE IN BATTERY WELL 1. PHYSIO ATTEMPTED TO REPLACE THE KEPS NUT FOR THE POSITIVE CONTACT IN BATTERY WELL 1; HOWEVER, DURING THE REPAIR PHYSIO OBSERVED THAT THE ENTIRE CONTACT PIN WAS LOOSE AND SPINNING WITHIN THE INSERT OF THE REAR CASE ASSEMBLY. PHYSIO THEN REPLACED THE REAR CASE ASSEMBLY 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 REAR CASE ASSEMBLY AND OBSERVED THAT THE GROMMET FOR THE BATTERY TERMINAL IN BATTERY WELL 1 WAS DAMAGED. THIS RESULTED IN THE CONTACT PIN LOCATED IN BATTERY WELL 1 TO SPIN AND THE GROUNDING WIRE TO REMAIN LOOSE, WHICH IN TURN CAUSED THE DEVICE TO INTERMITTENTLY POWER OFF BY ITSELF.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD POWER OFF BY ITSELF SHORTLY AFTER BEING POWERED ON. THIS OCCURRED MULTIPLE TIMES. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85744 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1