BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2950340 · Received February 8, 2013

    Report

    Report Number
    3015876-2013-00102
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 10, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES WERE DEPLETED. THE OFF-CURRENT WAS NORMAL AND NO MECHANICAL OR VISUAL ABNORMALITIES WERE FOUND.THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.THE CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A PREMATURE CHARGE PAK ICON PRESENT ON THE DISPLAY. UPON EXAMINATION OF THE UNIT, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54028 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1