BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSCO DELIVERY TABLE

    MDR report key: 93901 · Received May 30, 1997

    Report

    Report Number
    MW1011366
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    May 23, 1997
    Report Date
    May 28, 1997
    Manufacturer
    AMERICAN STERILIZER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LEG SUPPORT DEVICE IN QUESTION IN REPORT NUMBER MW1011366, WAS NOT MFG BY THIS FIRM. CO DOES NOT KNOW WHO THE MFR OF THE LEG SUPPORT IN QUESTION IS, AS A PART OF INVESTIGATION CO HAS CONTACTED THE USER FACILITY TO TRY TO ASSIST THEM IN DETERMINING WHO THE MFR OF THE SUPPORT IS, WITHOUT SUCCESS. IT SHOULD BE POINTED OUT THAT WHILE SURGICAL TABLE WAS IN USE AT THE TIME OF THE SURGICAL PROCEDURE, TO THE BEST OF CO'S KNOWLEDGE, NO PART OF THE AMSCO BRAND 2080 SURGICAL TABLE MFG BY STERIS MALFUNCTIONED AT ANYTIME DURING THE EVENT. THE TABLE MERELY SERVED AS A STABLE PLATFORM FOR THE PROCEDURE, AND DID NOT CAUSE OR CONTRIBUTE TO THE EVENT OR ANY ADVERSE OUTCOME ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO DELIVERY TABLE DELIVERY TABLE HDD AMERICAN STERILIZER 2080 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other