BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR2

    MDR report key: 2932700 · Received January 29, 2013

    Report

    Report Number
    1226420-2013-00019
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 28, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: METHOD: FACILITY NOT RETURNING PRODUCT THEREFORE NO EVALUATION TO COMPLETE. EVAL: RESULTS: FACILITY NOT RETURNING PRODUCT THEREFORE NO EVALUATION TO COMPLETE. EVAL: CONCLUSION: FACILITY NOT RETURNING PRODUCT THEREFORE NO EVALUATION TO COMPLETE. (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

    FACILITY ADVISED THERE IS INTERFERENCE WITH NEW EQUIPMENT IN EP LAB UPON ACTIVATION OF PLASMABLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38967 GENERATOR PULSAR2 GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1