BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY PERSONAL ALARM LOUD

    MDR report key: 1881506 · Received October 19, 2010

    Report

    Report Number
    2020362-2010-00294
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 21, 2010
    Manufacturer
    DONGGUAN POSEY MEDICAL DEVICE LTD.
    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). EVAL RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS AN INTERMITTENT ALARM TONE WHEN THE MAGNET IS OFF THE MAGNET PLATE. THE UNIT BATTERY DOOR IS MISSING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS WHILE IN USE THE ALARM WILL NOT SOUND. CUSTOMER MADE ATTEMPTS TO ADJUST THE VOLUME AND THE RESULTS REMAIN THE SAME. THE BATTERIES WERE REPLACED WITH THE SAME TYPE. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY PERSONAL ALARM LOUD KMI DONGGUAN POSEY MEDICAL DEVICE LTD. 8202L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI