BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3895285 · Received June 25, 2014

    Report

    Report Number
    3015876-2014-00711
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER ADVISED PHYSIO-CONTROL THAT THEY HAVE REPLACED THE THERAPY CONNECTOR ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE HAS SINCE BEEN RETURNED TO THE END USER FOR USE. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS NOT RECOGNIZING THE CONNECTION THROUGH THE THERAPY CONNECTOR ASSEMBLY. WITHOUT THIS CONNECTION RECOGNIZED, THE DEVICE WOULD BE UNABLE TO DELIVER DEFIBRILLATION ENERGY. THE CUSTOMER ADDITIONALLY REPORTED THAT THE DEVICE WOULD NOT WORK IN AED MODE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371822 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1