BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 4110805 · Received September 23, 2014

    Report

    Report Number
    3015876-2014-01112
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 9, 2014
    Report Date
    August 26, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED POWER PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A SHORTED TANTALUM CAPACITOR, DESIGNATOR C4.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S DEVICE WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589944 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1