BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4220204 · Received November 3, 2014

    Report

    Report Number
    3015876-2014-01301
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 6, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE DEVICE SHOWED ALL THREE INDICATORS (SERVICE WRENCH, CHARGE-PAK AND ATTENTION) IN THE DEVICE'S READINESS DISPLAY. THE DEVICE COULD NOT BE POWERED ON. 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.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND OBSERVED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES WERE DEPLETED. ONE OF THE INTERNAL HLC BATTERIES, DESIGNATOR BT2, DID NOT HOLD A CHARGE VERY WELL. A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD HOWEVER NOT BE DETERMINED. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE SHOWED A SERVICE WRENCH INDICATOR IN THE DEVICE'S READINESS DISPLAY. UPON EVALUATION OF THE DEVICE BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE SHOWED ALL THREE INDICATORS (SERVICE WRENCH, CHARGE-PAK AND ATTENTION) IN THE READINESS DISPLAY. THE DEVICE COULD NOT BE POWERED ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701209 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1