BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS BED

    MDR report key: 2843563 · Received October 24, 2012

    Report

    Report Number
    1824206-2012-06834
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 7, 2012
    Report Date
    October 7, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE HEAD SWITCH STICKING ON THE PT LEFT LOWER SIDE RAIL DUE TO A DAMAGED BUTTON FOR THE HEAD DOWN. THE ACCOUNT REPLACED THE PT LEFT LOWER SIDE RAIL LABEL TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE HEAD OF THE BED LOWERS ON ITS OWN. NO PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1