BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC

    MDR report key: 1920900 · Received December 6, 2010

    Report

    Report Number
    1824206-2010-11394
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH INSPECTED AND TESTED THE SIDERAILS AND FOUND ALL TO BE LATCHING PROPERLY. THE NURSE THOUGHT SHE PUT THE SIDERAIL UP, BUT WAS NOT 100% SURE.

    Description of Event or Problem · 1

    THE TECH WAS INFORMED BY THE ACCOUNTS STAFF THAT THEY FOUND A PATIENT LYING ON THE FLOOR WITH THE RIGHT INTERMEDIATE RAIL DOWN. NO ONE WITNESSED THE PATIENT FALL. NO INJURY. THE PATIENT RECEIVED TWO CT SCANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE BARIATRIC AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK