BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3143687 · Received June 3, 2013

    Report

    Report Number
    3015876-2013-00468
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL9, ON THE ANALOG PCB ASSEMBLY. THE CURRENT LEAKAGE DEPLETED THE INTERNAL HLC BATTERY AT A FASTER RATE. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS SHOWING THE SERVICE WRENCH INDICATOR. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT THE DEVICE DISPLAYED ALL THREE (CHARGE-PAK, ATTENTION AND WRENCH) ICONS AND IT WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244310 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1