BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BED SENSOR BELT

    MDR report key: 17347169 · Received July 18, 2023

    Report

    Report Number
    2182318-2023-00065
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Report Date
    June 23, 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 UNIT RECOGNIZED THE SENSOR BELT WHEN INSERTED INTO THE SENSOR RECEPTACLES; HOWEVER, THE UNIT DID NOT GO INTO MONITORING MODE WHEN HOOK AND LOOP FASTENER WERE CONNECTED OR ATTACHED DUE TO DISCONNECTED GREEN AND BLACK INTERNAL WIRES. THE SENSOR CABLE APPEARS TO BE PULLED EXCESSIVELY AS CREASES OBSERVED ON THE NARROW STRAP WHERE THE TWO STRESS RELIEF LOOPS ARE LOCATED CAUSING FOR NOT WORKING AS INTENDED. 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. POSSIBLE ROOT CAUSES FOR THIS DEFICIENCY: 1. THE BELT WAS APPLIED ONTO A PATIENT WHO IS COMBATIVE OR VERY AGGRESSIVE, 2. PATIENT WAS COOPERATIVE IN THE BEGINNING BUT BECAME EMOTIONAL OR FELT DISCOMFORT WITH THE PRODUCT AND BECAME AGGRESSIVE OR COMBATIVE, 3. CAREGIVERS DID NOT FOLLOW INSTRUCTIONS, OR THE PRODUCT WAS INCORRECTLY APPLIED. 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 # 8398. CUSTOMER STATES THAT PRODUCT # 8398 THE GREEN LIGHT WILL STAY ON WHEN THE BELT IS OPEN. THE BELT WILL NOT ARM/ACTIVATE CORRECTLY WHEN APPLIED CORRECTLY TO A PATIENT. PLEASE ADVISE TECH SERVICES ONCE PRODUCT HAS COMPLETED ITS INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872397 DISPOSABLE BED SENSOR BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP TIDI PRODUCTS LLC 8398 3115T127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown