BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR CONTROL UNIT

    MDR report key: 1160023 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04519
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH EXPECTED, THE SUSPECT DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION, THUS, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATOR CONTROL UNIT (HTA) WAS USED DURING A THERAPEUTIC HYDROTHERMAL ABLATION PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO SWITCH TO THE HTA UNIT, IT DID NOT POWER UP; NO LIGHTS OR MESSAGES ETC. AFTER TRYING A NEW CABLE, IT STILL WOULD NOT WORK. COMPLETED WITH ANOTHER OF SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR CONTROL UNIT MNB BOSTON SCIENTIFIC CORPORATION M006560010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK