BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 2133256 · Received May 11, 2011

    Report

    Report Number
    3015876-2011-00377
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    February 27, 2011
    Report Date
    April 12, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL DETERMINED THE CAUSE OF THE MALFUNCTION TO BE DUE TO DEPLETED INTERNAL HLC BATTERIES ON THE ANALOG PCB ASSEMBLY. BATTERY TWO OF THE INTERNAL HLC BATTERY WAS SHORTED. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHOWED THE ATTENTION ICON. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT WOULD NOT POWER ON. THERE WAS NO PT USE ASSOCIATED WITH THE 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