BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMSCO

    MDR report key: 1651064 · Received March 31, 2010

    Report

    Report Number
    MW5015394
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 31, 2010
    Manufacturer
    MEDICAL EQUIPMENT CONSULTANTS, INC.
    Product Code
    JEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT FELL FROM THE TABLE DURING SURGICAL PROCEDURE. TABLE TILTED DEEP TRENDELENBURG TO LOW POSITION AND HEAD OF BED 17 INCHES FROM THE FLOOR. PATIENT SLIPPED FROM UNDER THIGH SECURITY BELT ONTO THE FLOOR. INVESTIGATION ONGOING AS TO IF BED HAD ANY MALFUNCTION ISSUES. QUESTIONING NEW PADDING AS MORE SLIPPERY LESS RESISTANCE WITH SHEET AND PATIENT ON BED. NOTED ONE PAD HAD NO VELCRO ON CONTACT SIDE OF BED. DIAGNOSIS OR REASON FOR USE: SURGERY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO SURGICAL TABLE JEB MEDICAL EQUIPMENT CONSULTANTS, INC. AMSCO/3080 36051123

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR