BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1112103 · Received August 6, 2008

    Report

    Report Number
    3015876-2008-00878
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 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, AND ORDERING INFO TO REPLACE THE HARD PADDLES AND THE THERAPY CONNECTOR. THE REMOVED PARTS 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 CONTACTED PHYSIO-CONTROL TO REQUEST PARTS INFO TO REPLACE THE DEVICE'S HARD PADDLES AND THERAPY CONNECTOR. THE CUSTOMER REPORTED THAT A PIN BROKE FROM THE HARD PADDLES INTO THE THERAPY CONNECTOR. 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