BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2061839 · Received March 18, 2011

    Report

    Report Number
    3015876-2011-00257
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO- CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE THERAPY CONNECTOR ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED THERAPY CONNECTOR ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND FOUND THE CAUSE OF THE REPORTED PROBLEM TO BE A DEFORMED GROOVE FOR A CLIP, C.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE THERAPY CONNECTOR WAS LOOSE AND PULLED OUT FROM THE CASE. THE THERAPY CONNECTOR COULD BE UNAVAILABLE TO CONNECT TO THE THERAPY CABLE/PADDLES TO PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PT USE ASSOCIATED WITH THE 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