BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1901082 · Received November 10, 2010

    Report

    Report Number
    3015876-2010-01241
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL RECOMMENDED THE REPLACEMENT OF THE DEVICE'S THERAPY CABLE AND TO PERFORM A FULL INSPECTION ON THE DEVICE. THE CUSTOMER'S BIOMED LATER INDICATED THAT THE QUIK-COMBO THERAPY CABLE ASSEMBLY WAS REPLACED AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO SERVICE. THE REMOVED ASSEMBLY HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION; THEREFORE FURTHER INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S BIOMED THAT THE DEVICE'S THERAPY CABLE ASSEMBLY HAD A BENT PIN ON THE CONNECTOR. THE BIOMED INDICATED THAT WHEN TRYING TO STRAIGHTEN OUT THE PIN, IT BROKE OFF. THIS ISSUE WAS OBSERVED AFTER THE DEVICE FAILED A USER TEST AND THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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