BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BED SENSOR BELT

    MDR report key: 17653075 · Received August 30, 2023

    Report

    Report Number
    2182318-2023-00087
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Report Date
    July 27, 2023
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    PJP
    PMA / PMN Number
    K963413
    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 UNIT RECOGNIZED THE SENSOR BELT WHEN INSERTED TO THE SENSOR PORTS, BUT THE UNIT DOES NOT GO INTO MONITORING MODE WHEN THE HOOK AND LOOP FASTENERS WERE ATTACHED OR CONNECTED INDICATING THAT THE INTERNAL WIRES DID NOT HAVE A GOOD CONNECTION. THIS TYPE OF COMPLAINT IS A KNOWN ISSUE AND HAS BEEN ADDRESSED VIA CORRECTIVE ACTION. 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 COMPLIANT ON PRODUCT # 8398. (B)(6) IS PRIMARY. (B)(6) IS SECONDARY CONTACT. LIMITED INFORMATION GIVEN. CUSTOMER STATES THAT PRODUCT IS NONSPECIFICALLY DEFECTIVE. ADVISE TECH SERVICES ONCE INSPECTION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492552 DISPOSABLE BED SENSOR BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP TIDI PRODUCTS LLC 8398 3150T087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown