BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1081042 · Received July 18, 2008

    Report

    Report Number
    3015876-2008-00810
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE PART NUMBER AND ORDERING INFORMATION FOR A REPLACEMENT QUICK-COMBO THERAPY CABLE. THE DEFECTIVE CABLE IS NOT AVAILABLE FOR FURTHER EVALUATION BECAUSE THE CUSTOMER HAS DISPOSED OF IT. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE'S QUICK-COMBO THERAPY CABLE HAD AN INTERMITTENT CONNECTION. IF THE CABLE NEAR THE CONNECTOR IS BUMPED OR MOVED, IT CAN LOSE ITS CONNECTION. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

    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 NA