BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1171937 · Received September 19, 2008

    Report

    Report Number
    3015876-2008-01222
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE FOR OFF CURRENT LEAKAGE, AND DETERMINED THAT ROOT CAUSE FOR THE OBSERVED LEAKAGE WAS A CAPACITOR, DESIGNATOR C4, ON THE DIGITAL PCB ASSEMBLY.

    Description of Event or Problem · 1

    FOUND DURING INSPECTION. THE REPORTER STATED THAT DEVICE'S CHARGE-PAK, ATTENTION, AND SERVICE WRENCH ICONS WERE DISPLAYED, AND IT WOULD NOT POWER ON. THE REPORTER ALSO STATED THAT THE CHARGE-PAK WAS LABELED WITH AN EXPIRATION DATE OF 06/28/2006. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. PHYSIO-CONTROL EVALUATED THE DEVICE WITH A POWER SUPPLY AND OBSERVED EXCESSIVE CURRENT LEAKAGE, WHILE THE DEVICE WAS POWERED OFF, THAT WOULD CAUSE THE INTERNAL BATTERIES TO PREMATURELY CHARGE DEPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA