BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3041001 · Received April 8, 2013

    Report

    Report Number
    3015876-2013-00279
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE RETURNED DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES WERE VERY LOW AND WOULD NOT POWER THE DEVICE ON AND, AS A RESULT, THE UNIT WOULD NOT CHARGE AND PROVIDE DEFIBRILLATION THERAPY IF NEEDED. AFTER EXTENSIVE TROUBLESHOOTING THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON THE DISPLAY. THE THREE ICONS BEING ILLUMINATED INDICATES THAT THE DEVICE WOULD NOT LIKELY BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143733 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1