BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST

    MDR report key: 1061770 · Received June 13, 2008

    Report

    Report Number
    9615739-2008-00003
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED EMAIL FROM THE BIOMEDICAL DEPARTMENT OF AN INT'L AFFILIATE STATING THAT AS HE WAS INSPECTING THE BED, BEFORE DELIVERING IT TO THE HOSPITAL, HE FOUND THAT WHEN HE DEPRESSES THE BRAKE PEDAL, THE BRAKE WOULD NOT HOLD. HE STATED THAT THE PROBLEM IS IN THE CASTERS AT THE FOOT END OF THE BED. RECEIVED EMAIL FROM THE REPORTER STATING THAT HE INSTALLED THE NEW CASTERS WHICH RESOLVED THE ISSUE OF THE BRAKE NOT HOLDING.

    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