BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFX TABLE

    MDR report key: 227531 · Received June 8, 1999

    Report

    Report Number
    2126677-1999-00010
    Event Type
    Malfunction
    Date Received
    June 8, 1999
    Date of Event
    May 25, 1999
    Report Date
    June 8, 1999
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    JAA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT A BROKEN ANGULATION CHAIN CAUSED THE TABLE TO DROP FROM 45 DEGREES VERTICAL TO HORIZONTAL. NO APPARENT CAUSE FOR THE CHAIN FAILURE WAS IDENTIFIED. A REPLACEMENT CHAIN WAS ORDERED. THE PATIENT ON THE TABLE REPORTEDLY BUMPED HER HEAD ON THE TABLE AS THE TABLE TRAVELLED TO THE HORIZONTAL POSITION. SHE WAS CHECKED BY A DOCTOR AND WAS RELEASED WITHOUT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RFX TABLE DIAGNOSTIC X-RAY JAA GENERAL ELECTRIC MEDICAL SYSTEMS 46-194860G13 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *