BEUDAMED
    FDA Adverse Event Other Summary report: N

    V RISER

    MDR report key: 2349578 · Received November 17, 2011

    Report

    Report Number
    1931947-2011-00004
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION RESULTED IN THE FOLLOWING ANSWERS: IS THIS BED CAPABLE OF ACHIEVING NEAR VERTICAL 80 DEGREES TRENDELENBURG? NO. MAXIMUM ANGLE OF TRENDELENBURG IS 16 DEGREES BASED ON HEIGHT OF THE LEGS, LENGTH ON THE BED, AND GEOMETRY. WERE THERE ANY ELECTRICAL PROBLEMS FOUND UPON INSP BY (B)(4) TECH? NO ELECTRICAL PROBLEMS WERE FOUND. NOTE: (B)(4) HAS A VERY LARGE FLEET OF NOA BEDS WITH THEIR TECHS BEING HIGHLY TRAINED. FOR THIS REASON NOA DID NOT REQUEST THE BED RETURNED AND RELIED ON (B)(4) INSP. (B)(4). IS IT POSSIBLE THAT WEDGING THE FOOT END CONTROL BETWEEN MATTRESS AND FOOT BOARD CAUSED ACCIDENTAL ELEVATION AND TREND MOVEMENT? IT IS POSSIBLE. IF MULTIPLE BUTTONS ARE PRESSED, AS IN WEDGING, THERE IS NO MOVEMENT OF ELEVATION OR TREN. IF ONLY ONE BUTTON IS BEING PUSHED AT A TIME THEN THE ASSOCIATED MOVEMENT WILL OCCUR. CONCLUSIONS: IT IS NOT POSSIBLE FOR BED TO GO INTO T/RT ANGLE GREATER THAN 16 DEGREES. THE BED COULD MOVE IF ON BUTTON AT A TIME IS ACCIDENTLY PRESSED. THE HOSP HAS ISSUED STAFF INSTRUCTIONS TO SECURE FOOT END HANDSET CONSISTENT WITH SVC MANUAL. REFERENCE (B)(4).

    Description of Event or Problem · 1

    (B)(4). "THE BED ELEVATED AND THEN BEGAN MOVING BY ITSELF INTO A REVERSE TRENDELENBURG POSITION." "THE FAMILY WAS IN THE ROOM WHEN THIS HAPPENED AND THEY COULD NOT MAKE THE BED STOP. THEREFORE, THEY UNPLUGGED THE BED AND CALLED FOR HELP. WHEN THE RN ARRIVED IN THE ROOM, THE PT WAS ALMOST UPRIGHT AT AN 80 DEGREE ANGLE AND WAS SLIDING HEAD-FIRST TOWARDS THE FLOOR. STAFF USED A HOYER LIFT TO LIFT AND MOVE THE PT INTO A BED WITH A REGULAR BEDFRAME. THE PT'S PRESSURE ULCERS BEGAN BLEEDING WHEN THE HOYER LIFT WAS USED. THE RECOVERCARE BED WAS RETURNED TO THE RENTAL COMPANY, WHO INSP IT AND FOUND NO ELECTRICAL PROBLEMS, WIRING PROBLEMS, OR SHORTS, NO ELECTRICAL CURRENT LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V RISER AC POWERED ADJUSTABLE HOSPITAL BED FNL NOA MEDICAL INDUSTRIES, INC. 1040010BLK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other