BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 7729176 · Received July 27, 2018

    Report

    Report Number
    2020362-2018-00096
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Report Date
    May 15, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS PREVIOUSLY REPORTABLE UNDER THE ASR EXEMPTION E2015006, WHICH WAS REVOKED ON 2018/06/28, RESULTING IN THIS MDR SUBMISSION. EVALUATION FOUND THE UNIT HAS POWER BUT DOES NOT SOUND WHEN USED WITH A SENSOR OR MAGNET DUE TO A DEFECTIVE SPEAKER. OBSERVED STICKY RESIDE, DEEP SCRATCHES, SCUFF MARKS, WARNING LABEL, CONTROL BUTTON OPTIONS AND LED MODES WRITING HAS WORN OFF. BOTH DUST COVERS UNDERNEATH THE BATTERY SLOTS HAVE BEEN DAMAGED AND RATTLING SOUNDS CAN BE HEARD FROM INSIDE WHEN THE UNIT IS SHAKEN. THE VISUAL AND ADDITIONAL FINDINGS REVEALED SIGNS OF EXCESSIVE FORCE AND IMPACT SUCH AS DROPPING OR BUMPING THAT CONTRIBUTED TO THE FAULTY SPEAKER. 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 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 WARRANTED. MANUFACTURER REFERENCE FILE # (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED USING THE ALARM UNIT WITH THE MAGNET AND ONCE THE MAGNET IS DETACHED FROM THE ALARM THE UNIT DOES NOT SOUND. 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
    569482 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8345

    Patients

    Seq Age Sex Outcome Treatment
    1