BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCINTIBED TABLE

    MDR report key: 20755 · Received March 27, 1995

    Report

    Report Number
    MW1005578
    Event Type
    Malfunction
    Date Received
    March 27, 1995
    Date of Event
    February 27, 1995
    Report Date
    March 1, 1995
    Manufacturer
    SOPHA MEDICAL SYSTEMS, INC.
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CARBON FIBER TABLE HAD CRACKED AND WAS IN DANGER OF COLLAPSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCINTIBED TABLE NUCLEAR MEDICINE CAMERA SYSTEM IYX SOPHA MEDICAL SYSTEMS, INC. DSX

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other