BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BED SENSOR BELT

    MDR report key: 17283495 · Received July 7, 2023

    Report

    Report Number
    2182318-2023-00059
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Report Date
    May 26, 2023
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    PJP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: EVALUATION OF THE RETURNED PRODUCT FOUND THE RETURNED SENSOR BELT DID NOT SOUND WHEN THE HOOK AND LOOP FASTENERS ARE DISENGAGED. WHEN PRESSURE IS APPLIED CLOSER TO THE EYELET CONNECTORS, THE SENSOR BELT WOULD TRIGGER THE ALARM TO SOUND INDICATING THAT THERE IS A DISCONNECTED WIRE INSIDE. POSSIBLE CAUSE FOR THIS ISSUE IS WEAR AND TEAR, OPERATIONAL ERROR/MISUSE, AND /OR EXCESSIVE PULLING OF THE WIRING. BEING THAT THERE WERE SEVERAL COMPLAINTS FOR BELTS THAT DID NOT SOUND WHEN THE HOOK AND LOOK WERE DISENGAGED, THIS ISSUE IS BEING CONTAINED TO ADDRESS THE IDENTIFIED MISUSE. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES NEVER JERK OR PULL ON CORD TO REMOVE PLUG FROM ALARM. DOING SO MAY DAMAGE THE CORD OR PLUG AND MAY CAUSE THE BELT TO FAIL. ALWAYS USE PLASTIC TAB TO RELEASE THE PLUG. IF VELCRO STRAPS BECOME WET, ALARM MAY NOT SOUND. EXCESS MOISTURE MAY PREVENT SENSOR FROM ACTIVATING, INCREASING RISK OF INJURY. IF STRAPS BECOME WET, DISCONTINUE USE UNTIL COMPLETELY DRY. IF NECESSARY, USE A STIFF BRUSH TO REMOVE DUST AND LINT FROM HOOK- AND-LOOP. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS A PART OF THE MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED COMPLAINT VIA EMAIL FOR ITEM 8398 QTY: 3. BELT #1 3087T167: WHEN PLUGGED INTO THE POSEY ALARM, THE GREEN LIGHT STAYS ON EVEN WHEN THE BELT IS OPEN. BELT #2 3045T150: WHEN THE BELT IS APPLIED TO THE PATIENT AND CLOSED CORRECTLY, THE ALARM WILL NOT ACTIVATE (NO GREEN LIGHT). BELT #3 3059T061: WHEN THE BELT IS PLUGGED IN, THE POSEY ALARM WILL FLASH MULTIPLE COLORS OR IT WILL BE GREEN WHILE OPENED. DIFFERENT MALFUNCTIONS. REPORTED BY KELLY KENNEDY EMAIL (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543092 DISPOSABLE BED SENSOR BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP TIDI PRODUCTS LLC 8398 3087T167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown