BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR II

    MDR report key: 5001549 · Received August 13, 2015

    Report

    Report Number
    1226420-2015-00134
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION PROCESS: *PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -UNIT HAS A DENT ON REAR BOTTOM LEFT CORNER. *PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. DURING EVALUATION IN BIT SERVICE DEPARTMENT THE TECHNICIAN CHANGED THE FUSES TO POWER UP THE UNIT. THE UNIT DID NOT POWER UP SO AN INTERNAL INVESTIGATION WAS CONDUCTED AND FOUND THAT THE UNIT WAS PREVIOUSLY OPENED PRIOR TO RECEIVING. IT WAS FOUND THAT THE POWER CABLE WAS DISCONNECTED (UNPLUGGED) FROM THE POWER ASSEMBLY. TECHNICIAN RECONNECTED (PLUGGED IN) THE CABLES TO POWER THE UNIT UP. DURING POWER UP THE DC PCBA SPARKED AND COMPONENT C80 WAS DAMAGED. ROOT CAUSE: DC PCBA HAS DAMAGED COMPONENT¿REPLACING DC PCBA WILL ALLOW UNIT TO POWER UP. IT IS UNKNOWN HOW OR WHEN THESE CABLES WERE DISCONNECTED (UNPLUGGED.) DENT ON UNIT IS DUE TO IMPACT DAMAGE OUT IN THE FIELD. (B)(4).

    Description of Event or Problem · 1

    DURING INVESTIGATION AT AN MAE SERVICE CENTER, IT WAS IDENTIFIED THAT THE GENERATOR HAD DISCONNECTED INTERNAL WIRES LIKELY DUE TO USER TAMPERING. UPON RE-CONNECTION OF THESE WIRES, AN INTERNAL COMPONENT SPARKED CAUSING AN INCREASE IN CURRENT FLOW, RESULTING IN A FAILURE OF INTERNAL GENERATOR COMPONENTS. NO PATIENT INVOLVED THEREFORE NO PATIENT INFORMATION OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535066 GENERATOR PULSAR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1