BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1821001 · Received August 27, 2010

    Report

    Report Number
    3015876-2010-00974
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE QUIK-COMBO THERAPY CABLE 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 CABLE AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE REPORTED FAILURE TO BE AN OPEN WIRE BETWEEN TWO PINS, ONE AND THREE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE THE QUIK-COMBO THERAPY CABLE CONNECTION. HENCE, THE DEVICE WAS NOT ABLE TO PROVIDE DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. THERE WAS NO REPORT OF 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