BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2923193 · Received January 18, 2013

    Report

    Report Number
    3015876-2013-00055
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    November 8, 2012
    Report Date
    December 21, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REMOVED THE ANALOG PCB ASSEMBLY FOR FURTHER EXAMINATION AND OBSERVED THAT THE CAUSE OF THE REPORTED FAILURE WAS THAT ONE OF THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES, DESIGNATOR BT3, WOULD NO LONGER HOLD A CHARGE AND WAS LOSING VOLTAGE DAILY. THE OTHER HLC'S, BT1 AND BT2, REMAINED STABLE. PHYSIO WAS UNABLE TO DETERMINE WHAT CAUSED BT3 TO DEPLETE SO RAPIDLY. THE CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS DEPLETING CHARGE PAK'S AT A HIGHER RATE THAN EXPECTED. PHYSIO-CONTROL EXAMINED THE CUSTOMER'S RETURNED DEVICE AND OBSERVED THAT THE UNIT WOULD NOT REMAIN POWERED ON, WHICH PREVENTED THE DEVICE FROM CHARGING AND PROVIDING DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27932 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1