BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 201928 · Received December 16, 1998

    Report

    Report Number
    MW1015230
    Event Type
    Malfunction
    Date Received
    December 16, 1998
    Date of Event
    September 14, 1998
    Report Date
    December 9, 1998
    Manufacturer
    CARR CORP.
    Product Code
    IXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE WAS SHOCKED WHEN TURNING ON THE VIEWBOX. UPON INSPECTION OF THIS DEVICE, IT APPEARS THIS DEVICE HAD A MFG DEFECT THAT CAUSED A "HOT" WIRE FROM ONE OF BALLASTS TO BE PINCHED BY AN INTERNAL STAR WASHER AND CASE SCREW. TWO DISTINCT "SCORCH" MARKS WERE NOTED IN THE INTERIOR OF THE VIEWBOX, EVIDENCE OF AN ELECTRICAL ARC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * 4X4 PANEL VIEWBOX IXC CARR CORP. 4X4 PANEL *

    Patients

    Seq Age Sex Outcome Treatment
    1 *