BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE ESSENTIAL

    MDR report key: 3221333 · Received July 1, 2013

    Report

    Report Number
    2020362-2013-00303
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 5, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FORE VALUATION AND HAS NOT BEEN RECEIVED. NOTE: THIS REPORT IS BASED SOLELY ON THE REPORTED ISSUE. MANUFACTURER REFERENCE FILE NUMBER (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM DOES NOT SOUND WHEN THE MAGNET IS DETACHED FROM THE ALARM. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. CUSTOMER DID NOT PROVIDE A DATE WHEN DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297319 KEEPSAFE ESSENTIAL KMI J. T. POSEY CO. 8373 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAGNET: PART #8373M, LOT #UNK