BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 1960130 · Received December 17, 2010

    Report

    Report Number
    1824206-2010-11754
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH DISCOVERED, AFTER REMOVING THE COVER FROM THE PAN HOUSING LOGIC BOARD, A BURN ODOR. AFTER FURTHER VISUAL INSPECTION, THE TECH DISCOVERED BURNT COMPONENTS ON THE MOTOR CONTROL BOARD. THE TECH REPLACED THE MOTOR CONTROL BOARD TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT WHEN RAISING OR LOWERING THE BED, IT WOULD GO INTO TRENDELENBURG. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1