BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3071444 · Received April 22, 2013

    Report

    Report Number
    3015876-2013-00323
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 25, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE INTERNAL HLC BATTERIES WERE FULLY DEPLETED; HOWEVER FURTHER CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE HAD AN ILLUMINATED CHARGE-PAK ICON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE. UPON EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE CHARGE-PAK AND ATTENTION ICONS WERE DISPLAYED AND THE INTERNAL HLC BATTERIES WERE FULLY DEPLETED. THIS COULD HAVE PREVENTED DEFIBRILLATION THERAPY FROM BEING DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171490 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1