BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESSUREGUARD TURN SELECT

    MDR report key: 1213730 · Received October 23, 2008

    Report

    Report Number
    1041130-2008-00003
    Event Type
    Other
    Date Received
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS DESIGNED TO INCLUDE FIRM SIDE BOLSTERS, ENCOURAGING THE PT TO BE CENTERED ON THE MATTRESS. THE DESIGN OF THE PUMP AND INFLATION SYSTEM WOULD NOT ROLL A PERSON OFF THE MATTRESS. ACCORDING TO THE RN SURVEYOR, AN INVESTIGATION WAS NOT PERFORMED BY THE FACILITY AND THE INJURY WAS NOT REPORTED. THE DATE OF THIS INCIDENT IS UNKNOWN. THE PRESSUREGUARD TURN SELECT HAS BEEN ON THE MARKET SINCE 1997, WITH NO PREVIOUS INCIDENCES OF THIS NATURE.

    Description of Event or Problem · 1

    SPAN-AMERICA RECEIVED A CALL ON OCTOBER 9, 2008, FROM THE DEPARTMENT OF HEALTH AND AGING REPORTING THAT A WOMAN HAD ROLLED OFF THE PRESSUREGUARD TURN SELECT MATTRESS SYSTEM. SHE HIT HER HEAD, RESULTING IN A HEMATOMA. THE WOMAN HAS NO INDEPENDENT BED MOBILITY, AND THE FAMILY REPORTED THE INCIDENT TO THE DEPARTMENT OF HEALTH AND AGING. THE FACILITY NAME AND CONTACT PERSON WERE NOT PROVIDED TO SPAN-AMERICA. THIS COMPLAINT WAS NOT REPORTED TO SPAN-AMERICA BY THE FACILITY. THE RN SURVEYOR HAS CONCLUDED THAT THE FALL WAS MOST LIKELY RELATED TO A CARE ISSUE AND NOT THE PRODUCT ITSELF. IT IS BELIEVED THAT THE PT WAS LAYING ON THE EDGE OF THE BED WITH A WEDGE BEHIND HER BACK, AND SHE FELL OFF THE BED. USER INSTRUCTIONS INCLUDE POSITIONING THE PT IN THE CENTER OF THE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREGUARD TURN SELECT ALTERNATING PRESSURE MATTRESS FNM SPAN-AMERICA MEDICAL SYSTEMS, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1