BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TNA

    MDR report key: 5056004 · Received September 4, 2015

    Report

    Report Number
    1226420-2015-00148
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 7, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BIOMED PERFORMED PREVENTATIVE MAINTENANCE TESTING USING A DNI 454 ESU ANALYZER AND A TNA DEVICE AND FOUND THAT THE OUTPUT ON ALL SETTINGS BELOW COAG 5 WERE HIGHER THAN THE ALLOTTED TOLERANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590268 PLASMABLADE TNA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS300-002 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1