BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CHAIR ALARM BELT

    MDR report key: 14932916 · Received July 6, 2022

    Report

    Report Number
    2182318-2022-00078
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Report Date
    June 10, 2022
    Manufacturer
    TIDI PRODUCTS
    Product Code
    PJP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL FINDINGS OBSERVED CREASES AND LINT ON THE SENSOR BELT. THE FOAM STRAP HAS BEEN TORN APART ON ONE SIDE OF THE BOX STITCH NEAR THE BLUE HOOK AND LOOP. THE SENSOR IS FUNCTIONAL WHEN IN USE WITH THE IN-HOUSE 8345, BUT DUE TO THE FOAM STRAP BEING TORN APART THE SENSOR BELT WILL NOT PERFORM AS INTENDED. POSSIBLE CAUSES INCLUDE 1. THE CAREGIVER FAILED TO INSTRUCT THE PATIENT THE PURPOSE FOR AND HOW TO REMOVE THE BELT. THE PATIENT MAY HAVE WANTED TO REMOVE AND WAS UNCLEAR HOW TO EXIT THE BELT, CAUSING THE BELT TO BE TORN APART. 2. THE PRODUCT MAY HAVE BEEN APPLIED TO TIGHT CAUSING DISCOMFORT TO THE PATIENT. 3. THE PATIENT WAS COOPERATIVE AT INITIAL SET UP AND BECAME AGGRESSIVE / AGITATED AFTER CONTINUOUS USAGE OF THE PRODUCT. THE WARNING SECTION IN THE INSTRUCTIONS FOR USE IFU DOCUMENT M6269 STATES: DO NOT LEAVE PATIENT UNATTENDED UNLESS YOU ARE SURE PATIENT UNDERSTANDS PURPOSE FOR AND HOW TO REMOVE THE BELT. CHECK THAT BELT IS SNUG, BUT DOES NOT CAUSE ANY DISCOMFORT. POSEY SELF-RELEASING DISPOSABLE CHAIR ALARM BELTS ARE A NON-INVASIVE WAY TO MONITOR PATIENT MOVEMENT. HOWEVER, THESE DEVICES DO NOT PREVENT FALLS AND ARE NOT A SUBSTITUTE FOR GOOD NURSING CARE AND REGULAR VISUAL MONITORING. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANT. MANUFACTURER REFERENCE FILE (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA EMAIL THEY HAD THE BELT LOW ON THE PATIENT, HOWEVER PATIENT APPEARS TO HAVE GOTTEN HIS HANDS UNDER THE ENTIRE BELT AND PULLED UP LIKE A BICEP CRUNCH AND THE BELT RIPPED AT THE SEEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2844505 DISPOSABLE CHAIR ALARM BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP TIDI PRODUCTS 8399 1335T332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown