BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX BED

    MDR report key: 159648 · Received March 25, 1998

    Report

    Report Number
    159648
    Event Type
    Malfunction
    Date Received
    March 25, 1998
    Date of Event
    March 1, 1998
    Report Date
    March 23, 1998
    Manufacturer
    NOA MEDICAL INDUSTRIES
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DESIGN OF RESIDENT BED MAY CONTRIBUTE TO OPERATOR INJURY WHEN RAISING/LOWERING HEAD OF BED BY PINCHING/TRAPPING STAFF HAND/FINGERS/ARM BETWEEN STATIONARY BEDFRAME AND MOVABLE FRAME OF HEAD OF BED. FACILITY ADDED HANDLES TO MOVEABLE FRAME OF HEAD OF BED TO AVOID TRAPPING STAFF EXTREMITY BETWEEN BED FRAME. IN ADDITION, THE YELLOW COVER ON THE RELEASE LATCH PULLED OFF ON ONE BED AND CAUSED THE STAFF MEMBER TO DROP THE MATTRESS FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX BED ADJUSTABLE HEAD BED WITH HEAD/FOOT BOARDS FNJ NOA MEDICAL INDUSTRIES 1000033 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *