BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1845033 · Received September 13, 2010

    Report

    Report Number
    3015876-2010-01016
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED POWER PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND VERIFIED THE REPORTED/OBSERVED FAILURE. PHYSIO OBSERVED AN ELECTRICAL SHORT OF THE PCB BUT WAS UNABLE TO DETERMINE THE CAUSE OF THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON AC OR DC POWER. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT 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