BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAIR ALARM BELT LONG

    MDR report key: 9924343 · Received April 3, 2020

    Report

    Report Number
    2020362-2020-00046
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Report Date
    March 10, 2020
    Manufacturer
    POSEY PRODUCTS LLC
    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 · 1

    PRODUCT IS SCHEDULED TO BE RETURNED, BUT HAS NOT BEEN RECEIVED BY MANUFACTURER AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. THIS ALLEGED FAILURE COULD LEAD TO THE ALARM NOT SOUNDING AS INTENDED, WHICH COULD RESULT IN THE ALARM FAILING TO ALERT THE CAREGIVER OF A PATIENT EXIT. THIS LOSS OF FUNCTIONALITY COULD CONTRIBUTE TO A PATIENT INCIDENT. A HISTORICAL COMPLAINT DATA REVIEW FOUND NO SIMILAR COMPLAINTS OF PATIENTS SLIPPING OUT OF OR DEFEATING THE BELT REPORTED FOR THIS PRODUCT LINE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED BY THE CUSTOMER. 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 PROVIDED ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE 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 WARRANTED. (B)(4).

    Description of Event or Problem · 1

    TERRITORY MANAGER WILL BE PROVIDING AN IN-SERVICE TO THE REQUESTED CUSTOMER. TWO INCIDENTS HAVE OCCURRED, ONE PATIENT FALL. PATIENTS WILL BE ABLE TO SLIDE UNDER THE BELT OR PULL IT ABOVE THEIR HEAD. TROUBLESHOOTING GUIDE SAVED, NO GTIN NUMBER PROVIDED. THIS FILE IS FOR EVENT # 2 OF 2, NO PATIENT FALL OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386190 CHAIR ALARM BELT LONG FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP POSEY PRODUCTS LLC 8399L

    Patients

    Seq Age Sex Outcome Treatment
    1