BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGERY TABLE

    MDR report key: 17015 · Received October 20, 1994

    Report

    Report Number
    MW1003746
    Event Type
    Malfunction
    Date Received
    October 20, 1994
    Date of Event
    September 19, 1994
    Report Date
    October 10, 1994
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT LYING SUPINE ON OR TABLE. ONE NURSE AT FOOT OF BED HOLDING PT'S LEGS AND ONE NURSE AT PT'S LEFT SIDE ATTACHING LEG HOLDER TO TABLE. TABLE TOP SUDDENLY TILTED TO RIGHT APPROX 45 DEGREES. PT WAS GRABBED BY NURSES, TABLE TOP LEVELED AND PT TRANSFERRED TO OR CART, THEN TO ANOTHER SURGERY TABLE. FURTHER INVESTIGATION SHOWED THAT WHEN THE MFR WAS INSTALLING AN UPGRADE KIT TO PREVENT THIS, A LOCKING SCREW WAS OMITTED. PROBLEM HAS BEEN CORRECTED, AND OTHER TABLES CHECKED FOR SIMILAR OMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGERY TABLE SURGERY TABLE FQO AMERICAN STERILIZER CO. 3080RL (BL58728200)

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other