BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1071859 · Received July 8, 2008

    Report

    Report Number
    3015876-2008-00773
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE PART NUMBERS REQUIRED TO REPLACE THE CONNECTOR AND THE ADULT HARD PADDLES. THE REPLACED CONNECTOR AND PADDLES WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVAL. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HAD A PIN BREAKING OFF FROM THE DEVICE'S HARD PADDLES CONNECTOR AND WAS NOW SITTING IN THE THERAPY CONNECTOR. THE CUSTOMER WAS UNABLE TO REMOVE THE BROKEN PIN. THERE WAS NO PT 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