BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 4121591 · Received July 29, 2014

    Report

    Report Number
    2020362-2014-00251
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 27, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. THE UNIT'S VOICE MESSAGE DOES NOT PLAY WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD, ONLY A CLICKING SOUND IS HEARD. THE UNIT'S TONE PLAYS PROPERLY. THERE IS BATTERY LEAKAGE AND CORROSION ON THE BATTERY FLAT CONTACTS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE ALARM IS SET TO VOICE AND TONE MODE, THE PRE-RECORDED MESSAGE IS NOT HEARD. THE REPORTED ISSUE WAS DISCOVERED DURING SET UP, BUT THE DATE OF THE EVENT IS UNKNOWN. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442715 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CHAIR SENSOR, SQUARE, 6-MONTH, MODEL 8308,| LOT # UNKNOWN.