BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1812825 · Received August 13, 2010

    Report

    Report Number
    3015876-2010-00935
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL PROVIDED THE THIRD PARTY BIOMED TECHNICAL ASSISTANCE AND THE ENERGY SELECT PCB ASSEMBLY PART NUMBER INFORMATION TO TROUBLE SHOOT THE REPORTED ISSUE AND REPAIR THE DEVICE. FOLLOW UP WITH THE REPORTER FOUND THAT THE BIOMED RECEIVED THE ENERGY SELECT PCB AND IS IN THE PROCESS OF REPAIRING THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT DISCHARGE CHARGED ENERGY AT ANY OTHER ENERGY LEVELS EXCEPT 360 JOULES. THE DEVICE WOULD GIVE A CONSTANT ESCALATING TONE AND FAILED TO DISCHARGE ENERGY. THERE WAS NO KNOWN PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA