BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3821552 · Received May 20, 2014

    Report

    Report Number
    3015876-2014-00570
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 28, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THERE WAS AN INTERMITTENT SHORT CAUSED BY A TIN WHISKER LOCATED ON A CABLE-MOUNTED PLUG CONNECTOR, DESIGNATOR P506, CRIMP SIDE, AT LANDS 2 AND 3, ON THE DEVICE'S SWITCH FLEX CABLE ASSEMBLY. THE INTERMITTENT SHORT CAUSED THE DEVICE TO THINK THAT THE CHARGE-PAK WAS MISSING AND DRAW EXCESSIVE CURRENT, WHICH LED TO THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES DEPLETING. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD DISPLAYED A PREMATURE LOW-BATTERY INDICATOR. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED INTERNAL ELECTRICAL LEAKAGE THAT LED TO THE DEPLETION OF THE DEVICE'S INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES, WHICH COULD INHIBIT THE DEVICE'S ABILITY TO PROVIDE DEFIBRILLATION THERAPY, IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300373 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1