BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST

    MDR report key: 1112734 · Received August 11, 2008

    Report

    Report Number
    9615739-2008-00010
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE SCALE ON THIS BED DOES NOT WEIGH ACCURATELY AND IS OFF AS MUCH AS SEVEN POUNDS. THE HILL-ROM TECHNICIAN REPLACED AND CALIBRATED THE SCALE BOARD TO RESOLVE THE ISSUE. THERE WERE NO REPORTED ADVERSE EVENTS ASSOCIATED WITH THIS PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREASSIST AC POWERED HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1