BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 7729054 · Received July 27, 2018

    Report

    Report Number
    2020362-2018-00086
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Report Date
    May 24, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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    THIS DEVICE WAS PREVIOUSLY REPORTABLE UNDER THE ASR EXEMPTION E2015006, WHICH WAS REVOKED ON 2018/06/28, RESULTING IN THIS MDR SUBMISSION. THE DEVICE WAS RECEIVED IN WITH SIGNS OF DROPPING OR BUMPING. SCRATCHES TO THE EXTERIOR HOUSING, BATTERY COMPARTMENT AND A MISSING BATTERY DOOR WAS OBSERVED. THE UNIT PASSED ALL FUNCTIONAL TESTING WHEN USED WITH A SENSOR PAD. HOWEVER, THE DEVICE DID NOT SOUND WHEN IN USE WITH THE PULL MAGNET. UPON OPENING THE UNIT, A FAULTY REED SWITCH WAS NOTED. BEING THAT THE DEVICE IS OVER THREE YEARS OLD, IT IS LIKELY THE CAUSE IS EXPECTED NORMAL WEAR AND TEAR. 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARMS IS NOT SOUNDING WHEN POWERED UP AND THE LIGHT FLASHES WHEN SET TO VOICE AND TONE. 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
    570545 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8345

    Patients

    Seq Age Sex Outcome Treatment
    1