BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3963253 · Received July 29, 2014

    Report

    Report Number
    3015876-2014-00862
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    April 21, 2014
    Report Date
    July 2, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE INTERNAL HLC BATTERIES APPEARED TO BE DEPLETED. AFTER A THOROUGH DEVICE INVESTIGATION, THE CAUSE OF THE DEPLETED INTERNAL HLC BATTERIES COULD NOT BE DETERMINED. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS SHOWING ITS LOW BATTERY (ATTENTION) ICON. AFTER EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE INTERNAL HLC BATTERIES HAD BEEN COMPLETELY DEPLETED. WITHOUT A CHARGE IN THE INTERNAL HLC BATTERIES, THE DEVICE WOULD NOT HAVE SUFFICIENT POWER TO PROVIDE EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441126 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1