BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOA MEDICAL INDUSTRIES

    MDR report key: 21092230 · Received January 7, 2025

    Report

    Report Number
    1931947-2024-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    July 9, 2024
    Report Date
    October 31, 2024
    Manufacturer
    NOA MEDICAL INDUSTIRES
    Product Code
    FNL
    UDI-DI
    00817492012745
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN HOUSE INVESTIGATION FOUND A SLIGHT TOLERANCE ISSUE ON THE FRAMES THAT ALLOWED THE LATCH ATTACHMENT PINS TO MOVE, CATCHING THE BUTTON ON THE COVER AND EITHER BREAKING IT OR HANGING UP ON THE COVER AND GETTING STUCK. BUTTON WAS ATTACHED TO THE LATCH WITH PLASTIC PINS THAT BROKE EASILY. THE RED BUTTON WAS REDESIGNED TO SHORTEN AND BE HELD IN PLACE WITH SCREWS INSTEAD OF PINS. CHANGED LATCH ATTACHMENT PINS TO A THREADED ROD AND PLATES WHICH SECURES THE LATCH TO PREVENT MOVEMENT. PIN LENGTH ON THE BACK OF THE LATCH WAS ALSO FOUND TO AFFECT PERFORMANCE. CUSTOMER WAS SENT NEW DESIGN. A CORRECTION IS PLANNED TO REPLACE FRAME ASSEMBLY (FRAME, LATCH, RED BUTTON).

    Description of Event or Problem · 0

    (B)(4), CUSTOMER REPORTED ISSUE WITH THE RIGHT-SIDE HEAD SIDE RAIL. WHEN PRESSING THE RELEASE BUTTON, THE SIDE RAIL GETS STUCK. THERE IS A METAL PIECE THAT NEEDS TO RETRACT WHEN PUSHING THE RED BUTTON, BUT IT DOES NOT RETRACT COMPLETELY, AND THAT IS WHY THE SIDERAIL GETS STUCK. DEVICE WAS NOT RETURNED FOR INVESTIGATION. SIDE RAIL IS PART OF THE BED PACKAGE. THERE ARE NO PROBLEMS WITH THE BED ITSELF. REPORT IS BEING FILED AFTER THE 30 DAY TIMEFRAME DUE TO CONFUSION REGARDING THE FILING OF MDRS WITH LITTLE INFORMATION. WE ARE REPORTING THE INFORMATION REASONABLY KNOWN TO US OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321147 NOA MEDICAL INDUSTRIES SIDE RAIL SET - HEAD - BEHAVIORAL HEALTH BED (GRAY) FNL NOA MEDICAL INDUSTIRES 7540209LGRY 00817492012745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other