BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3915490 · Received February 25, 2014

    Report

    Report Number
    2020362-2014-00058
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Report Date
    January 24, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED TO BE RETURNED AND HAS NOT BEEN RECEIVED. NOTE: THIS REPORT IS BASED SOLELY ON THE CUSTOMER'S REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS POWER, BUT DOES NOT SOUND WHEN THE MAGNET PULL CORD IS DETACHED FROM THE ALARM. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY AND THERE IS NO VISIBLE DAMAGE TO THE ALARM. CUSTOMER DID NOT PROVIDE A DATE WHEN THE ISSUE WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116108 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SITTER SELECT MAGNET: PART # 8361M, LOT # UNK