BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3112584 · Received May 14, 2013

    Report

    Report Number
    3015876-2013-00395
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 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): THE CAUSE FOR THE MALFUNCTION WAS DETERMINED TO BE AN ELECTRICALLY LEAKY FILTER, FL9, ON THE ANALOG PCB ASSEMBLY. THE ELECTRICAL LEAKAGE DEPLETED THE INTERNAL HLC BATTERIES.A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAD ALL THREE (CHARGE-PAK, ATTENTION AND WRENCH) ICONS ILLUMINATED. THE CHARGE-PAK, INTERNAL BATTERY CHARGER, WAS REPLACED BUT THE ATTENTION AND WRENCH ICONS REMAINED. PHYSIO-CONTROL EVALUATED THE DEVICE LOG AND OBSERVED THAT THE DEVICE INTERNAL BATTERY WAS DEPLETED FOR A CERTAIN PERIOD OF TIME. FURTHERMORE, PHYSIO FOUND A MALFUNCTION THAT DEPLETED THE INTERNAL HLC BATTERY AT A RAPID RATE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212195 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1