BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY WIRELESS IR ALARM

    MDR report key: 1901096 · Received November 10, 2010

    Report

    Report Number
    2020362-2010-00350
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 12, 2010
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT DURING SET-UP, THERE IS NO ALARM TONE WHEN MOTION IS DETECTED BY THE MOTION SENSOR. CUSTOMER TESTED THE PRODUCT WITH NEW BATTERIES. THERE IS NO DAMAGE DETECTED ON THE CASING. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY WIRELESS IR ALARM KMI J. T. POSEY CO. 8376 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI