BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOA MEDICAL TALL SOFT TOUCH SIDE RAIL

    MDR report key: 2017022 · Received March 2, 2011

    Report

    Report Number
    1931947-2011-00001
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 17, 2011
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ACTUAL INJURIES OCCURRED BUT THE POSSIBILITY OF INJURY WAS PRESENT. THE THREADS ON 1 OF 2 THREADED ATTACHMENT PINS WERE STRIPPED. WHEN THE 550 LBS RESIDENT ROLLED AGAINST THE SIDE RAIL, THE STRIPPED THREAD LET GO, OR PULLED OUT, CAUSING PIN 2 OF 2 TO FAIL (SNAP OFF). NOA HAS IMPROVED THE DESIGN OF THE "TALL SOFTTOUCH SIDE RAIL" P.N 7540011BEI TO ELIMINATE THE NEED FOR THE CUSTOMER TO INSTALL AND PERFORM PERIODIC INSPECTION AND MAINTENANCE ON THE THREADED ATTACHMENT PINS. THE NEW DESIGN SIDE RAIL, P.N 7540027BEI HAS FACTORY INSTALLED, WELDED, MAINTENANCE FREE ATTACHMENT PINS. THE NEW DESIGN IS CURRENTLY SHIPPING FOR ALL BEDS RATED OVER 600 LBS.

    Description of Event or Problem · 1

    LONG TERM CARE RESIDENT APPROX 550 LBS TURNED TO LEFT SIDE FOR BATHING AND RAIL "SNAPPED". RESIDENT ON FLOOR. ADMITTED TO HOSPITAL. NO INJURIES WERE FOUND. SHE WAS RELEASED FROM THE HOSPITAL THE NEXT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOA MEDICAL TALL SOFT TOUCH SIDE RAIL HOSPITAL BED SIDE RAIL FNL NOA MEDICAL INDUSTRIES, INC. 7540011BEI NM21

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization