BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3822716 · Received May 21, 2014

    Report

    Report Number
    3015876-2014-00578
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE BUT COULD NOT VERIFY THE REPORTED FAILURE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    THE THIRD-PARTY SERVICE AGENT FURTHER EVALUATED THE DEVICE. DURING LONG-TERM TESTING THE FAILURE COULD NOT BE REPRODUCED. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. FOLLOWING EVALUATION, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHYSIO-CONTROL THAT THEIR DEVICE SUDDENLY SHUT DOWN DURING MONITORING OF A PATIENT. ACCORDING THE CUSTOMER'S REPORT, THE BATTERIES THAT WERE PLACED INTO THE DEVICE BEFORE THE REPORTED EVENT, WERE FULLY CHARGED. THERE WAS NO NEGATIVE OUTCOME FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303656 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR