BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARM SENSOR, EZ CLEAN ALARM BELT

    MDR report key: 8488840 · Received April 5, 2019

    Report

    Report Number
    2020362-2019-00065
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Report Date
    March 11, 2019
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS SCHEDULED TO BE RETURNED BUT HAVE NOT BEEN RECEIVED IN YET AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION 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 PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS 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. MANUFACTURER REFERENCE FILE # (B)(4). NO PRODUCT RETURNED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ISSUE WITH THE BELT IS THE WIRING THAT IS CONNECTED TO THE PLUG. THEY COME LOOSE RESULTING IN EITHER INTERMITTENT OR NO ALARM. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280115 ALARM SENSOR, EZ CLEAN ALARM BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP POSEY PRODUCTS LLC 8358

    Patients

    Seq Age Sex Outcome Treatment
    1