BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC

    MDR report key: 1843720 · Received September 21, 2010

    Report

    Report Number
    1824206-2010-10060
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN REPLACED THE HEAD WELDMENT, RETRACTING ARMS, HEAD SENSOR AND EXTRUSION BRACKETS TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED THAT THE HEAD WELDMENT WAS OUT OF EACH SIDE EXTRUSION BRACKET CAUSING A BENT HEAD CYLINDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE BARIATRIC A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1840

    Patients

    Seq Age Sex Outcome Treatment
    1