BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3123084 · Received May 21, 2013

    Report

    Report Number
    3015876-2013-00418
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 24, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 EXCESSIVE CURRENT LEAKAGE DEPLETED THE INTERNAL HLC BATTERIES AT A RAPID RATE.A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS SHOWING THE CHARGE-PAK (THE INTERNAL BATTERY CHARGER)ICON. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THE CHARGE-PAK AND ATTENTION ICONS. FURTHERMORE, PHYSIO FOUND THAT THE DEVICE COULD NOT STAY POWERED ON AS THE INTERNAL HLC BATTERY WAS DEPLETED. THE DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION THERAPY IN THE OBSERVED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223453 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1