BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOA MEDICAL INDUSTRIES

    MDR report key: 21091763 · Received January 7, 2025

    Report

    Report Number
    1931947-2023-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 5, 2023
    Report Date
    October 28, 2024
    Manufacturer
    NOA MEDICAL INDUSTRIES
    Product Code
    FNL
    UDI-DI
    00817492012745
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LATCH IS A TWO STEP PROCESS WHERE THE BUTTON MUST BE PUSHED IN AND THE SIDE RAIL MOVED. THERE IS A POSSIBILITY THAT THEY DIDN'T GET THE SIDE RAIL PUSHED ALL THE WAY UP TO CAUSE THE BUTTON TO POP OUT AND THE RAIL TO LOCK INTO PLACE. A REPLACEMENT WAS SENT TO THE CUSTOMER. WE WERE WAITING FOR THE PART TO RETUN INCLUDING CONTACTING TWICE AND SENDING A RETURN LABEL. DEVICE WAS NOT RETURNED FOR INSPECTION SO A MALFUNCTION COULD NOT BE DETERMINED. 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. A CORRECTION IS PLANNED TO REPLACE FRAME ASSEMBLY (FRAME, LATCH, RED BUTTON).

    Description of Event or Problem · 0

    (B)(4), ON TUE, DEC 5, 2023 AT 9:41AM WE RECEIVED AN EMAIL ALLEGING THAT THE RED BUTTON ON THE SIDE RAIL THAT RELEASES THE RAIL TO DROP DOWN WAS STUCK INSIDE AND DOESN'T POP OUT AS IT SHOULD TO LOCK THE RAIL IN PLACE. THE RAIL ISN'T LOCKING INTO PLACE, WHICH ALLOWED HIM TO FALL OUT OF HIS BED DUE TO THE RAIL DROPPING FROM THE UPRIGHT POSITION. FORTUNATELY, HE IS OKAY BUT THE RAIL IS NOT. INCIDENT WAS REPORTED FROM A USER VIA A DISTRIBUTOR, NO OTHER INFORMATION WAS PROVIDED. WE SENT A REPLACEMENT WITH A RETURN LABEL SO THE DEVICE COULD RETURN FOR INVESTIGATION. WE REACHED OUT AGAIN LATER WHEN THE PART HAD NOT RETURNED OFFERING TO SEND ANOTHER RETURN LABEL BUT NEVER HEARD BACK FROM THE CUSTOMER. WE COULD NOT DETERMINE THAT A MALFUNCTION OCCURED. REPORT IS BEING FILED AFTER THE 30 DAY TIMELINE DUE TO CONFUSION OVER THE FILING OF MDRS WITH LITTLE INFORMATION. WE ARE REPORTING WITH THE INFORMATION REASONABLY KNOWN TO US OUT OF AN ABUNDANCE OF CAUTION. SIDE RAIL IS PART OF THE BED PACKAGE. THERE ARE NO PROBLEMS ASSOCIATED WITH THE BED ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868974 NOA MEDICAL INDUSTRIES SIDE RAIL SET - FOOT BEHAVIORAL HEALTH BED (GRAY) FNL NOA MEDICAL INDUSTRIES 7540228LGRY 00817492012745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other