BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURN SELECT

    MDR report key: 1695391 · Received May 18, 2010

    Report

    Report Number
    1041130-2010-00005
    Event Type
    Other
    Date Received
    May 18, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 17, 2010
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEM, INC.
    Product Code
    CCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) (DISTRIBUTOR) SAID THE FACILITY HAS DONE A COMPLETE INVESTIGATION AND REPORT ON THE EVENT. THEY ARE "CONVINCED" THAT OUR PRODUCT HAD NOTHING TO DO WITH THE EVENT. THE PATIENT WAS 90 LBS AND HAD LIMITED MUSCLE CONTROL; HOWEVER, SHE WAS ON THE SIDE OF THE BED WITH THE RAIL "DOWN." THE FACILITY HAS DONE RE-TRAINING ON POSITIONING AND THE USE OF RAILS. I HAVE REQUESTED A COPY OF THEIR FULL REPORT. THIS PRODUCT HAS BEEN COMMERCIALIZED FOR 13 YEARS AND WE HAVE NEVER HAD AN EVENT WHERE THIS PRODUCT TOSSED A PATIENT FROM BED. THE PRODUCT DESIGN HAS MANY SAFETY FEATURES TO PREVENT THIS, BOTH IN THE PUMP AND INFLATION SYSTEM. THE PUMPS PRESSURE RELIEVE VALVE WILL ACTIVATE WHEN THE PRESSURE ASSUMES A CERTAIN LEVEL AND THE INFLATION SYSTEM IS ENCLOSED IN A MATERIAL THAT WILL "HOLD" THE TUBES FROM EXPANDING. A CONVERSATION WITH THE D.O.N. AT THE FACILITY ALSO CONFIRMED THE INVESTIGATION AND REPORT WERE DONE AND THE PATIENT WAS NOT INJURED DURING THE FALL. THE FACILITY IS HAPPY WITH THE PRODUCT AND IT IS BACK IN USE.

    Description of Event or Problem · 1

    REPORTED THAT THE TURN SELECT TOSSED A PATIENT OUT OF BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURN SELECT TURN SELECT CCX SPAN-AMERICA MEDICAL SYSTEM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1