BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1033060 · Received April 23, 2008

    Report

    Report Number
    3015876-2008-00375
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO REPLACED THE DIGITAL PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION. PHYSIO FURTHER EVALUATED THE REPLACED DIGITAL PCB ASSEMBLY AND DETERMINED THAT ROOT CAUSE WAS AN IC CHIP, DESIGNATOR U2.

    Description of Event or Problem · 1

    FOUND DURING TESTING BY PHYSIO-CONTROL. DEVICE RETURNED FROM DISTRIBUTOR FOR CREDIT, NO REASON GIVEN, CHARGEPAK AND ATTENTION ICONS DISPLAYED. PHYSIO EVALUATED THE DEVICE AND OBSERVED THAT OPERATION LOCKED UP WHEN THE POWER BUTTON WAS PRESSED.

    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