BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2182111 · Received June 23, 2011

    Report

    Report Number
    3015876-2011-00492
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY BIOMED REPORTED THAT THE QUIK-COMBO CABLE WIRE WAS BROKEN AT THE END OF THE CONNECTOR. PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND THE QUIK-COMBO THERAPY CABLE PART NUMBER INFO FOR ORDERING A REPLACEMENT. SEVERAL ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER FOR ADDITIONAL INFO AND RESOLUTION TO THE REPORTED ISSUE HAVE NOT BEEN SUCCESSFUL.

    Description of Event or Problem · 1

    DURING A PT USE, IT WAS REPORTED THAT THE DEVICE WOULD NOT DELIVER A DEFIBRILLATION SHOCK THROUGH THE QUIK-COMBO THERAPY CABLE. THE USER SWITCHED TO PADDLES AND PROVIDED TREATMENT. THE RPTR WAS NOT AWARE OF THE PT OUTCOME. THERE WAS NO REPORT OF ADVERSE EVENT OR FURTHER DETAILS ON THE EVENT/PT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK