BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2853872 · Received December 3, 2012

    Report

    Report Number
    3015876-2012-00866
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 7, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL DETERMINED THE CAUSE FOR THE FAILURE TO BE THE THERAPY CABLE. PHYSIO-CONTROL REPLACED THE THERAPY CABLE OUT OF THE CUSTOMER'S STOCK. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE PHYSIO-CONTROL SERVICE AGENT THAT THE CUSTOMER'S DEVICE WOULD NOT CHARGE DEFIBRILLATION ENERGY. ON THE DISPLAY OF THE DEVICE THE MESSAGE 'CONNECT CABLE' WAS SHOWN. THE DEVICE WAS TAKEN OUT OF SERVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1