BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA ECT MACHINE

    MDR report key: 2303272 · Received October 18, 2011

    Report

    Report Number
    MW5022689
    Event Type
    Malfunction
    Date Received
    October 18, 2011
    Date of Event
    September 9, 2011
    Report Date
    October 3, 2011
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE ADMITTED FOR DEPRESSION WITH A PHM OF COLON CANCER. WHILE THE PATIENT WAS UNDER ANESTHESIA ON (B)(6) 2011 FOR RIGHT UNILATERAL ECT, THE DOCTOR WAS UNABLE TO DELIVER TREATMENT DUE TO INCREASED IMPEDANCE AND THE TREATMENT WAS ABORTED. BIOMED NOTIFIED FOR EVALUATION, INSPECTION AND REPAIR OF THE EQUIPMENT. MACHINE FUNCTIONING PROPERLY WHEN CHECKED BY BIOMED AND WAS SUBSEQUENTLY USED ON (B)(6) 2011 FOR ECT TREATMENT. THE ECT MACHINE WAS SENT TO THE MANUFACTURER FOR A PLANNED SOFTWARE UPGRADE. A LOANER MACHINE IS BEING USED FOR ECT TREATMENTS WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECTA ECT MACHINE ECT MACHINE GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other