BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY PERSONAL ALARM LOUD

    MDR report key: 2243157 · Received August 31, 2011

    Report

    Report Number
    2020362-2011-00287
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Report Date
    July 8, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED POWER, BUT THE ALARM DOES NOT SOUND WHEN THE MAGNET IS REMOVED FROM THE MAGNET PLATE. THE UNIT DOES NOT PASS FUNCTIONAL TESTS. THE TONE SELECTOR FEATURES AND LOW BATTERY INDICATOR WORK PROPERLY. THE BATTERY DOOR IS MISSING FROM THE UNIT. NOTE: POSEY INSTRUCTION FOR USE WARNING STATEMENT: PERFORM SYSTEM TEST AND REMOVE THE MAGNET TO ACTIVATE THE ALARM. ALWAYS VERIFY YOU CAN HEAR THE ALARM VOLUME AT THE FURTHEST POSSIBLE DISTANCE BEFORE LEAVING THE PT/RESIDENT UNATTENDED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS NO POWER. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY. THERE WAS NO VISIBLE DAMAGE REPORTED. THERE WAS NO PT CONTACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY PERSONAL ALARM LOUD KMI J. T. POSEY CO. 8202L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA