BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1964224 · Received December 22, 2010

    Report

    Report Number
    3015876-2010-01400
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL REPLACED THE THERAPY PCB 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 PCB ASSEMBLY AT THE FAILURE ANALYSIS CTR AND FOUND A WHITE RESIDUE LIQUID ON THE PCB. HOWEVER, FURTHER CAUSE OF THE MALFUNCTION WAS NOT DETERMINED AS THE PCB PASSED ADDITIONAL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE USER TEST AND THE SERVICE LIGHT WAS ILLUMINATED. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT WAS NOT ABLE TO DETECT THE THERAPY CABLE CONNECTION. THE DEVICE WAS UNABLE TO DELIVER 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