BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE RISER

    MDR report key: 2503670 · Received March 20, 2012

    Report

    Report Number
    1931947-2012-00001
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 16, 2012
    Manufacturer
    NOA MEDICAL INDUSTRIES INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR LARGE ORDERS, BEDS ARE SHIPPED STANDING VERTICAL ON "SHIPPING FEET." THE HEAD AND FOOT DECKS ARE SECURED DURING SHIPMENT WITH LARGE PINK ZIP TIES. A WARNING LABEL, PART NUMBER 1200032, "8.5" X 6" RED - DO NOT CUT PINK TIE, HAS BEEN ADDED TO THE BOM FOR EVERY TYPE OF BED MANUFACTURED BY NOA. THE WARNING LABEL IS ATTACHED TO THE PINK ZIP TIE ITSELF AND INSTRUCTS THE INSTALLER TO LOWER THE BED INTO THE HORIZONTAL POSITION RESTING ON ITS CASTERS BEFORE CUTTING THE PINK ZIP TIES. THERE WAS NO ACTUAL INJURY.

    Description of Event or Problem · 1

    BED WAS STANDING VERTICAL ON SHIPPING FEET. THE PINK ZIP TIE THAT SECURES THE HEAD DECK DURING SHIPPING WAS CUT AND THE HEAD DECK FELL FORWARD AND ALMOST HIT THE MAINTENANCE MAN WHO CUT THE ZIP TIE. NO ACTUAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE RISER A.C. POWERED HOSPITAL BED FNL NOA MEDICAL INDUSTRIES INC 1050008BEI-T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other