BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 1062231 · Received June 17, 2008

    Report

    Report Number
    1824206-2008-02669
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 31, 2005
    Report Date
    May 31, 2005
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLAINT AND RISK ASSESSMENT REVIEW, IT WAS DETERMINED THAT THIS TYPE OF FLUID INGRESS HAS THE POTENTIAL TO CAUSE SERIOUS INJURY THROUGH CROSS CONTAMINATION AND IS THEREFORE BEING REPORTED LATE. THE TECHNICIAN REPLACED THE MATTRESS TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    AN ACCOUNT STATED THAT FLUID LEAKED THROUGH THE TICKING INTO THE FOAM OF THE MATRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1