BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 12763413 · Received November 7, 2021

    Report

    Report Number
    2020362-2021-00069
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Report Date
    October 12, 2021
    Manufacturer
    POSEY PRODUCTS, LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL FINDINGS OBSERVED RED STICKER NOTE ATTACHED ON THE FRONT SIDE OF THE UNIT STATING THAT THE UNIT DID NOT SOUND WHEN CLIP WAS OFF. INDENTATIONS AND SITE STICKERS OBSERVED ON THE EXTERIOR HOUSING. SENSOR PIN 4 INSIDE THE SENSOR RECEPTACLE INTERSECTED TO PIN 3. THE BATTERY DOOR IS MISSING. EVALUATION FOUND THE UNIT DID NOT SOUND WHEN IN USE WITH A PULL MAGNET DUE TO SENSOR PIN 4 INSIDE THE SENSOR RECEPTACLE CROSSED OVER TO SENSOR PIN 3. AFTER PIN 4 WAS MOVED TO ITS ORIGINAL LOCATION, THE UNIT SOUNDED AND FUNCTIONED PROPERLY. IT IS NOT KNOWN HOW PIN 4 CROSSED OVER TO PIN 3 SINCE THIS IS NOT EASILY TO BE MOVED WITHOUT MANEUVERING FROM ITS ORIGINAL LOCATION, BUT IT IS THE CAUSE OF HAVING NO SOUND WHEN IN USE WITH THE MAGNET. BEING THAT THE UNIT IS ALREADY MORE THAN TWO YEARS OLD SINCE IT WAS MANUFACTURED, IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE UNIT NOT SOUNDING, AND THE LIKELY CAUSE OF THE EVENT IS NORMAL WEAR AND TEAR. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS A PART OF THE MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY AT THIS TIME. (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN ALARM THAT WILL NOT PROPERLY ALARM WHEN TRIGGERED. NO GTIN NUMBER PROVIDED. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659799 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS, LLC 8345 1909KF0289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown