BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS BED

    MDR report key: 2922716 · Received December 28, 2012

    Report

    Report Number
    1824206-2012-08682
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE MOUNTING BRACKET WHERE THE HEAD LIFT ARM ATTACHES TO THE INTERMEDIATE FRAME HAS A BROKEN WELD. NO FURTHER INFO IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.

    Description of Event or Problem · 1

    THE TECHNICIAN ALLEGED THE HEAD LIFT ARM WAS DETACHED FROM THE INTERMEDIATE FRAME. THE BED DID NOT COLLAPSE BUT THE INTERMEDIATE FRAME WAS UNSTABLE. NO PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1