BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BED SENSOR BELT

    MDR report key: 17302597 · Received July 11, 2023

    Report

    Report Number
    2182318-2023-00060
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Report Date
    June 12, 2023
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    PJP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    117

    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 DUE TO INTERNAL WIRES HAVE SEPARATED FROM THE TERMINAL. POSSIBLE CAUSE FOR THIS ISSUE IS 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 IS REPORTING A COMPLAINT ON PRODUCT # 8389 LOT# 3031T124. (B)(4). CUSTOMER STATES THAT BRAND NEW BELT TAKE FROM PACKAGING AND APPLIED TO A PATIENT WOULD NOT ACTIVATE. TRIED A NEW BELT WITH SAME ALARM AND IT WORKED. PLEASE ADVISE WHEN THE PRODUCT INSPECTION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241167 DISPOSABLE BED SENSOR BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP TIDI PRODUCTS LLC 8398 3031T124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown