BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 11913675 · Received June 1, 2021

    Report

    Report Number
    2020362-2021-00030
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Report Date
    May 10, 2021
    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

    VISUAL FINDINGS OBSERVED ONE OF THE DUST COVERS UNDERNEATH THE BATTERY SLOT WAS BROKEN. EVALUATION FOUND THE UNIT DID NOT SOUND WHEN IN USE WITH A MAGNET CORD DUE TO A FAULTY REED SWITCH. THE UNIT PASSED ALL OTHER FUNCTIONAL TESTING WHEN IN USE WITH SENSOR PAD. THE VISUAL FINDINGS REVEALED SIGN OF DROPPING OR BUMPING THAT MAY HAVE CONTRIBUTED TO THE FAULTY REED SWITCH. 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 · 1

    THE CUSTOMER CONTACTED US VIA PHONE CALL. THE CUSTOMER STATES THAT THE ALARM IS MAKING NO AUDIBLE SOUND. THE LIGHTS BLINK BUT NO SOUND WHEN YOU TURN THE ALARM ON AND NO SENSOR OR MAGNET IS ATTACHED. CUSTOMER STATES THAT THE BATTERY COMPARTMENT AREA IS FREE OF MOISTURE OR CORROSIVE DAMAGE. THE NC AND SENSOR PORT LOOKS DAMAGE FREE AS WELL. NO GTIN INFORMATION WAS AVAILABLE. THE CUSTOMER WAS TOLD ABOUT THE 4 YEAR USEFUL LIFE WARRANTY. A TS TEMPLATE HAS BEEN COMPLETED AND SAVED TO THE DRIVE. 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
    812844 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS, LLC 8345 2022KF1682

    Patients

    Seq Age Sex Outcome Treatment
    1