BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 7728870 · Received July 27, 2018

    Report

    Report Number
    2020362-2018-00093
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Report Date
    May 17, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    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    THIS DEVICE WAS PREVIOUSLY REPORTABLE UNDER THE ASR EXEMPTION E2015006, WHICH WAS REVOKED ON 2018/06/28, RESULTING IN THIS MDR SUBMISSION. EVALUATION FOUND THE UNIT DOES NOT SOUND WHEN IN USE WITH THE PULL MAGNET DUE TO A FAULTY REED SWITCH. THE VISUAL FINDINGS OBSERVED SCRATCHES ON THE EXTERIOR HOUSING. THE BATTERY DOOR IS MISSING AND BOTH DUST COVERS UNDERNEATH THE BATTERY SLOTS AND ONE SIDE OF THE MOUNTING SLOT HAVE BEEN DAMAGED. THE VISUAL FINDINGS REVEALED SIGNS OF DROPPING OR BUMPING THAT MAY CONTRIBUTE TO THE FAULTY REED SWITCH. 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 WHEN THE ALARM IS SET TO TONE AND USED WITH THE PULL MAGNET THE ALARM WILL 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
    570743 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8345

    Patients

    Seq Age Sex Outcome Treatment
    1