BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BED SENSOR BELT

    MDR report key: 17406328 · Received July 27, 2023

    Report

    Report Number
    2182318-2023-00068
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Report Date
    June 29, 2023
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    PJP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: EVALUATION OF THE RETURNED PRODUCT FOUND THE UNIT DID NOT RECOGNIZE THE SENSOR BELT WHEN PLUGGED IN TO THE UNIT SENSOR RECEPTACLES. ADDITIONALLY, IT DID NOT SOUND WHEN THE HOOK AND LOOP WERE DISENGAGED DUE TO A BROKEN BLACK WIRE INSIDE. THE BLACK WIRE BROKE OFF AS IT WAS PUNCTURED BY A NEEDLE DURING THE STITCHING PROCESS OF INSTALLING THE WHITE LOOP FASTENER. POSSIBLE ROOT CAUSES FOR THIS DEFICIENCY: 1.) THE BLACK WIRE WAS NOT COMPLETELY BROKEN DURING THE STITCHING PROCESS AND WAS FUNCTIONING AS INTENDED DURING THE FINAL INSPECTION, BUT AFTER A PERIOD OF TIME THE WIRE BROKE OFF CAUSING FOR NOT FUNCTIONING AS INTENDED, 2.) THE SENSOR BELT WAS NOT PART OF THE AQL (ACCEPTABLE QUALITY LIMIT) SAMPLES AT THE FINAL INSPECTION STEP. THE QUALITY DEPARTMENT AT THE TIJUANA FACILITY WAS MADE AWARE OF THE FINDING TO PREVENT THIS ISSUE FROM REOCCURRING. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY SIMILAR FINDING OF PUNCTURED WIRE CAUSING TO BREAK APART AGAINST THIS DEVICE IN THE PAST 2 YEARS. THEREFORE, IT APPEARS THIS COMPLAINT WAS AN ISOLATED EVENT. 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. 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

    CTS REPORTED COMPLAINT VIA EMAIL. ITEM 8398 IS NOT PROPERLY CONNECTING TO THE ALARM AND WILL NOT FUNCTION AS INTENDED. CTS HAS MADE ATTEMPTS OF TROUBLESHOOTING, CANNOT RESOLVE. LOT #2235T061.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817527 DISPOSABLE BED SENSOR BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP TIDI PRODUCTS LLC 8398 2235T061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown