BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CHAIR ALARM BELT

    MDR report key: 12381007 · Received August 27, 2021

    Report

    Report Number
    2020362-2021-00052
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Report Date
    April 28, 2021
    Manufacturer
    POSEY PRODUCTS
    Product Code
    PJP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL FINDINGS OF THE RETURNED PRODUCT OBSERVED THAT THE SENSOR CABLE APPEARED TO BE STRETCHED AS IT HAS SCRATCHES AND FOAM STRAP DEFORMATIONS AT THE TWO CABLE RELIEF LOOPS. HAIR FOUND ON THE BLUE HOOK FASTENER. EVALUATION OF THE UNIT FOUND THAT THE SENSOR BELT DID NOT TRIGGER THE 8345 TEST UNIT WHEN THE WHITE HOOK AND LOOP WERE NOT CONNECTED DUE TO INTERNAL WIRING NOT BEING INSTALLED PROPERLY. THIS ALLEGED LOSS OF FUNCTIONALITY COULD LEAD TO THE ALARM NOT SOUNDING AS INTENDED, WHICH COULD RESULT IN THE ALARM FAILING TO ALERT THE CAREGIVER OF A PATIENT EXIT. AWARENESS AND RE-TRAINING OF THE PRODUCTION TEAM WAS PERFORMED TO PREVENT THE ISSUE FROM REOCCURRING. 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY AT THIS TIME. (B)(4).

    Description of Event or Problem · 0

    CUSTOMER IS REPORTING VIA EMAIL BELT ALARM BELTS THAT DO NOT PROPERLY FUNCTION. THEY PREVIOUSLY BEGAN TO ALARM WHEN THEY WERE NOT CONNECTED, AS WELL AS RESULTED IN A PATIENT BEING FOUND ON THE FLOOR (NO INJURY). ITEMS RETURNED FOR EVALUATION. NO GTIN NUMBER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277714 DISPOSABLE CHAIR ALARM BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP POSEY PRODUCTS 8399 0329T072

    Patients

    Seq Age Sex Outcome Treatment
    1