BEUDAMED
    FDA Adverse Event Other Summary report: N

    AP RISER

    MDR report key: 2434056 · Received November 17, 2011

    Report

    Report Number
    1931947-2011-00005
    Event Type
    Other
    Date Received
    November 17, 2011
    Date of Event
    September 15, 2011
    Report Date
    November 15, 2011
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION RESULTED IN THE FOLLOWING ANSWERS: NOTE: (B)(4) HAS A VERY LARGE FLEET OF NOA BEDS WITH THEIR TECHNICIANS BEING HIGHLY TRAINED. FOR THIS REASON NOA DID NOT REQUEST THE BED RETURNED AND RELIED (B)(4) INSPECTION. CONCLUSIONS: IT IS NOT POSSIBLE FOR BED TO GO INTO T/RT ANGLE GREATER THAN 16 DEGREES. THE BED COULD MOVE IF ONE BUTTON AT A TIME IS ACCIDENTLY PRESSED. THE HOSP HAS ISSUED STAFF INSTRUCTIONS TO SECURE FOOT END HANDSET CONSISTENT WITH SERVICE MANUAL.

    Description of Event or Problem · 1

    (B)(4). "ON THE DAY OF THE EVENT THE PT WAS LYING IN A (B)(4) LOW BED THAT BEGAN RISING UP AND LOWERING, THEN MOVED INTO A TRENDELENBURG POSITION BY ITSELF. THE PT WAS FOUND AT 80 DEGREE ANGLE AND WAS MOVED TO A REGULAR BED WITH MATS. PT WAS NOT HARMED BY THE EVENT. THE (B)(4) BED WAS RETURNED TO THE RENTAL COMPANY, WHO INSPECTED IT AND FOUND NO ELECTRICAL PROBLEMS, WIRING PROBLEMS, OR SHORTS, NO ELECTRICAL CURRENT LEAKS. THIS MODEL OF THE BEDS HAS 2 HAND CONTROLS, ONE AT THE FOOT OF THE BED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP RISER AC POWERED ADJUSTABLE HOSPITAL BED FNL NOA MEDICAL INDUSTRIES, INC. 1040001BLK/SUB

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other