BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4130486 · Received September 30, 2014

    Report

    Report Number
    3015876-2014-01150
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 8, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL9, FROM THE ANALOG PCB ASSEMBLY. THE LEAKY FILTER DEPLETED THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES OF THE DEVICE WHICH PREVENTED IT FROM POWERING ON. 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 THAT THE DEVICE WOULD NOT POWER ON. ADDITIONALLY, ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) WERE PRESENT ON THE DISPLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609507 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1