BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4186119 · Received October 20, 2014

    Report

    Report Number
    3015876-2014-01239
    Event Type
    Malfunction
    Date Received
    October 20, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE OF THE INTERNAL HLC BATTERIES BEING DEPLETED THROUGH THE ELECTRONIC DEVICE DOWNLOAD. AFTER A THOROUGH DEVICE EVALUATION, A CONCLUSIVE CAUSE OF THE REPORTED DEPLETED HLC BATTERIES COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING ITS CHARGE-PAK AND ATTENTION ICONS. AFTER REVIEW OF THE DEVICE DOWNLOAD IT WAS OBERVED THAT THE INTERNAL HLC BATTERIES WERE DEPLETED. WITH DEPLETED INTERNAL HLC BATTERIES, THE DEVICE WOULD LIKELY NOT HAVE THE ABILITY TO DELIVER ADEQUATE DEFIBRILLATION THERAPY.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664420 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1