BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3191928 · Received June 27, 2013

    Report

    Report Number
    3015876-2013-00555
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A THIRD PARTY AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. HE THEN REPLACED THE POWER PCB ASSEMBLY AND THE CABLE ASSEMBLY WHICH CONNECTS THE SYSTEM PCB TO THE INTERFACE PCB. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    THE FAILED POWER PCB ASSEMBLY WAS RETURNED TO PHYSIO-CONTROL FOR FURTHER EVALUATION. PHYSIO OBSERVED THAT THE INTEGRATED CIRCUIT, DESIGNATOR U5, LOCATED ON THE POWER PCB ASSEMBLY WAS NOT FUNCTIONING. THE CAUSE OF THE REPORTED FAILURE WAS DUE TO THE INTEGRATED CIRCUIT U5, LOCATED ON THE POWER PCB ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAILY CHECK, THE DEVICE DID NOT POWER ON. THE HOSPITAL MAINTENANCE SERVICE FIRST ATTEMPTED TO REPAIR THE DEVICE WITH NO SUCCESS AND THE DEVICE'S CONFIGURATION WAS LOST. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293532 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1