BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3000367 · Received March 12, 2013

    Report

    Report Number
    3015876-2013-00195
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WITH THE THIRD PARTY BIOMED CONFIRMED THAT REPLACEMENT OF THE THERAPY CONNECTOR ASSEMBLY RESOLVED THE REPORTED DEVICE FAILURE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. THE REMOVED THERAPY CONNECTOR WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND THE THERAPY CONNECTOR REPLACEMENT PART NUMBER INFORMATION. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS/REPAIR.

    Description of Event or Problem · 1

    A THIRD PARTY BIOMED REPORTED THAT THE DEVICE THERAPY CABLE CONNECTOR HAD AN INTERMITTENT CONNECTION WHEN MOVED. THE DEVICE DUMPED CHARGED ENERGY AND WAS UNABLE TO PROVIDE DEFIBRILLATION THERAPY WHEN THE ISSUE OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102914 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1