BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE, NO POWER

    MDR report key: 4121592 · Received July 29, 2014

    Report

    Report Number
    2020362-2014-00248
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 26, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT DID NOT CONFIRM THE REPORTED ISSUE OF POWER. THE UNIT HAS POWER WHEN THE UNIT IS POWERED WITH BATTERIES. WHEN THE UNIT IS TESTED FOR VOICE MESSAGE ONLY, THE UNIT'S VOICE MESSAGE DOES NOT PLAY REPEATEDLY; IT ONLY PLAYS ONCE. WHEN THE UNIT IS TESTED FOR VOICE AND TONE, THE UNIT ONLY PLAYS THE VOICE MESSAGE; THE UNIT DOES NOT PLAY THE SELECTED TONE. THE UNIT PASSED ALL OTHER FUNCTIONAL TESTING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM WILL NOT POWER ON. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. NO VISIBLE DAMAGE REPORTED. CUSTOMER DISCOVERED ISSUE DURING SET-UP, BUT DID NOT PROVIDE A DATE WHEN FOUND. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442819 POSEY KEEPSAFE DELUXE, NO POWER KMI J. T. POSEY CO. 8374NP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OVER MATTRESS SENSOR, PART # 8307, LOT #UNK