BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMEAIRE ARS FOR CAREASSIST

    MDR report key: 1213733 · Received October 23, 2008

    Report

    Report Number
    1041130-2008-00002
    Event Type
    Other
    Date Received
    October 23, 2008
    Date of Event
    March 20, 2008
    Report Date
    September 23, 2008
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC. CONTRACT MANUFACTURES FOR HILL-ROM
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    FACILITY RECEIVED NOTICE OF A COMPLAINT ALLEGING INJURY FROM HILL-ROM IN 2008. FACILITY IS A CONTRACT MANUFACTURER FOR HILL-ROM FOR THE PRIMEAIRE ARS MATTRESS FOR CAREASSIST. THE CAREASSIST MATTRESS IS MARKETED BY HILL-ROM WITH THE CAREASSIST BED. HILL-ROM IS PERFORMING THE INVESTIGATION FOR THE CAREASSIST BED SYSTEM RELATIVE TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEAIRE ARS FOR CAREASSIST NONPOWERED AIR FLOTATION MATTRESS FNM SPAN-AMERICA MEDICAL SYSTEMS, INC. CONTRACT MANUFACTURES FOR HILL-ROM

    Patients

    Seq Age Sex Outcome Treatment
    1