BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1812969 · Received August 17, 2010

    Report

    Report Number
    3015876-2010-00940
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED SEVERAL EVENT CODES LOGGED IN THE MEMORY. PHYSIO 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 CENTER AND WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. FURTHER CAUSE FOR THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ILLUMINATED A SERVICE INDICATION WHILE THE USER ATTEMPTED TO MONITOR A PT DURING TRANSPORT. THE DEVICE USE HAD NO ADVERSE EFFECTS TO THE PT. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED. FOLLOWING THE EVENT, PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND SEVERAL EVENT CODES LOGGED IN THE MEMORY INDICATING A POSSIBLE CRITICAL 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 UNK