BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 3061025 · Received March 26, 2013

    Report

    Report Number
    9615739-2013-00085
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPLACED THE SCALE BOARD BUT THE ALLEGED ISSUE REMAINS. THE ACCOUNT REPLACED THE EXTERNAL ALARM ASSEMBLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE PT POSITION ALARM IS FAINT AND COULD NOT BE HEARD OUTSIDE THE ROOM THAT THE BED IS IN. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122996 CARE ASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1170

    Patients

    Seq Age Sex Outcome Treatment
    1