BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 4862476 · Received June 23, 2015

    Report

    Report Number
    3015876-2015-00696
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED LOSS OF POWER. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE LOST POWER. THE PATIENT WAS BEING MONITORED AND THERE WAS NO REPORT OF DEFIBRILLATION THERAPY BEING NEEDED. THE CUSTOMER INDICATED THAT THEY DID NOT KNOW THE BATTERY LEVELS AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF ANY ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406368 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1