BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONAL ALARM LOUD

    MDR report key: 2010051 · Received March 2, 2011

    Report

    Report Number
    2020362-2011-00050
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Report Date
    January 31, 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) - THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT THE ALARM HAS INTERMITTENT POWER WHEN TESTED WITH NEW BATTERIES. 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