BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY PERSONAL ALARM

    MDR report key: 2000103 · Received February 3, 2011

    Report

    Report Number
    2020362-2011-00029
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    January 6, 2011
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED, THE ALARM DID NOT SOUND WHEN THE PULL CORD IS DETACHED FROM THE ALARM. THERE IS A SINGLE CHIRP HEARD WHEN THE BATTERY IS CONNECTED. THE BATTERY CONNECTOR FITS LOOSE ON THE BATTERY. THERE IS NO VISIBLE DAMAGE TO THE ALARM CASE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ALARM WILL NOT SOUND WHEN THE PULL CORD IS DETACHED FROM THE ALARM. THE BATTERY WAS REPLACED WITH A NEW SUPPLY. WHEN THE BATTERY IS INSERTED INTO THE ALARM, A CHIRP IS HEARD. THE BATTERY DOOR IS NOT DAMAGED AND CLOSES PROPERLY. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI