BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 2000 W/SCALE

    MDR report key: 1850409 · Received September 20, 2010

    Report

    Report Number
    1824206-2010-10032
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT WANTED AN EXPLANATION OF HOW THE BED EXIT IS SUPPOSED TO OPERATE ON THE BED. TECHNICAL SUPPORT EXPLAINED THE PROPER OPERATION OF THE BED EXIT FUNCTION. ACCOUNT WILL TEST THE BED EXIT SYSTEM AND CALL BACK. THREE ATTEMPTS HAVE BEEN MADE REGARDING A RESOLUTION TO THIS CONTACT LINE, WITH NO RESPONSE.

    Description of Event or Problem · 1

    ACCOUNT STATED THAT A NURSE ALLEGED THAT THE BED EXIT DID NOT ALARM WHEN THE PT LEFT THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 2000 W/SCALE A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P1145

    Patients

    Seq Age Sex Outcome Treatment
    1