BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 2053605 · Received March 17, 2011

    Report

    Report Number
    1824206-2011-01618
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN FOUND THAT WHEN THE CUSTOMER APPLIED THE BRAKES, THE TIRE DID NOT ROLL BUT THE CASTER WOULD STILL SWIVEL DIRECTIONALLY AND WHEN CUSTOMER APPLIED THE STEER, THE CASTERS DID NOT LOCK DIRECTIONALLY. THEY WOULD STILL SWIVEL. CUSTOMER WAS ABLE TO PUT PEDAL IN ALL THREE POSITIONS. REPLACED BOTH FOOT CASTERS TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED ALLEGED THAT THE FOOT CASTERS WILL NOT LOCK DIRECTIONALLY IN STEER OR BRAKE MODE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P3200

    Patients

    Seq Age Sex Outcome Treatment
    1