BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT MACHINE

    MDR report key: 34285 · Received July 19, 1996

    Report

    Report Number
    MW1009528
    Event Type
    Malfunction
    Date Received
    July 19, 1996
    Date of Event
    June 27, 1996
    Report Date
    July 9, 1996
    Manufacturer
    MECTA CORP.
    Product Code
    GXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BROUGHT TO BIOMEDICAL ENGINEERING FOR REPAIR OF BROKEN STIMULUS OUTPUT CONNECTOR. CO REFUSED TO SELL $1.51 REPLACEMENT PART TO HOSP. INSISTED THAT WHOLE UNIT BE RETURNED TO FACTORY FOR REPAIR AT AN ESTIMATED COST OF $300.00 PLUS SHIPPING AND RENTAL FOR AN INTERIM LOANER. REPAIRED WITH SAMPLE SUPPLIED BY LOCAL VENDOR FOR FREE. DURING REPAIR FOUND SEVERAL SMALL SCREWS ROLLING AROUND LOOSE INSIDE THE DEVICE. THE SCREWS WERE INTENDED TO FASTEN THE EXTERNAL PLASTIC FEET TO THE UNIT. THESE HAD BROKEN OFF, APPARENTLY TOO FLIMSY TO SUPPORT THE WEIGHT OF THE MACHINE. ALSO NOTICED THAT THE OLDER VERSION PT ECG/EEG CABLE COULD BE PLUGGED INTO THE REMOTE STIMULUS CONNECTOR ON THE NEWER MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECT MACHINE ECT MACHINE GXC MECTA CORP. SR1

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO