BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONAL ALARM LOUD

    MDR report key: 2140702 · Received June 15, 2011

    Report

    Report Number
    2020362-2011-00209
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 25, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: EVAL OF THE PRODUCT FOUND THE ALARM SOUNDED WHEN IT SHOULD INITIALLY BUT WHEN THE MAGNET WAS PLACED BACK ON THE MAGNET PLATE AND REMOVED, THE ALARM DID NOT SOUND AS IT SHOULD. THE ALARM FUNCTION IS INTERMITTENT. THE TONE SELECTOR AND LOW BATTERY INDICATOR DOES NOT WORK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM POWERS ON AND THEN POWERS OFF AT TIMES. THE CUSTOMER REPORTED THE ALARM HAS NO VISIBLE DAMAGE ON THE ALARM CASE OR BATTERY COMPARTMENT. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI