BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3903073 · Received June 30, 2014

    Report

    Report Number
    3015876-2014-00743
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 4, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO THEN 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.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF A DIODE, DESIGNATOR CR1.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE HAD LOGGED AN EVENT CODE AND WAS OUT OF CALIBRATION. UPON AN EVALUATION OF THE DEVICE BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE COULD NOT DELIVER DEFIBRILLATION THERAPY BECAUSE IT WOULD NOT DETECT A CONNECTION THROUGH THE PADDLES LEAD.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381200 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1