BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 2863266 · Received November 1, 2012

    Report

    Report Number
    9615739-2012-00391
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    HILL-ROM PLUVIGNER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE CASTER ROD SLID OUT OF THE LONG BRAKE TUBE FROM A BROKEN CASTER COVER. THE TECHNICIAN REPLACED THE BRAKE CASTER COVER TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE TECHNICIAN ALLEGED THAT THE HEAD END BRAKE CASTERS WILL NOT HOLD. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM PLUVIGNER 1170

    Patients

    Seq Age Sex Outcome Treatment
    1