BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1233858 · Received November 13, 2008

    Report

    Report Number
    3015876-2008-01630
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND OBSERVED THAT THE INTERNAL BATTERY WAS DEPLETED AND LEAKAGE CURRENT WHEN THE DEVICE IS OFF WAS EXCESSIVE. PHYSIO DETERMINED THAT THE CAPACITOR, DESIGNATOR C177, WAS ROOT CAUSE FOR THE EXCESSIVE OFF-CURRENT AND DEPLETED INTERNAL BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS DISPLAYING ALL THE SERVICE ICONS. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. WHEN THE DEVICE WAS RECEIVED AND THEN EVALUATED BY PHYSIO-CONTROL, IT WAS ALSO OBSERVED THAT THE DEVICE WOULD NOT POWER UP. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THIS EVENT.

    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