BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3023646 · Received March 27, 2013

    Report

    Report Number
    3015876-2013-00241
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS ABLE TO VERIFY THE REPORTED FAILURE. PHYSIO OBSERVED THAT A BATTERY CELL, DESIGNATOR BT3 WAS DEPLETED; HOWEVER THE CAUSE OF THE DEPLETED BATTERY CELL COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS DISPLAYING ALL THREE ICONS (ATTENTION, CHARGE-PAK, AND SERVICE WRENCH). THIS ISSUE IS INDICATIVE OF A DEVICE THAT WOULD NOT HAVE SUFFICIENT POWER TO PROVIDE DEFIBRILLATION SHOCKS TO A PATIENT, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126296 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1