BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE ALARM

    MDR report key: 2241321 · Received September 2, 2011

    Report

    Report Number
    2020362-2011-00312
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 5, 2011
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. NOTE: THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY STATEMENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE AC ADAPTER IS CONNECTED TO THE ALARM THE POWER IS INTERMITTENT; THE CONNECTION DOES NOT APPEAR LOOSE. THE CUSTOMER TRIED THE ADAPTER WITH A DIFFERENT OUTLET AND THE RESULTS REMAIN THE SAME. THERE WAS NO PT CONTACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE DELUXE ALARM KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA