BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE NO POWER SWITCH

    MDR report key: 2221738 · Received August 17, 2011

    Report

    Report Number
    2020362-2011-00268
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 18, 2011
    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
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT THERE IS CORROSION IN THE BATTERY COMPARTMENT. THE AQUA-ALERT WATER INDICATOR LABEL SHOWS MOISTURE EXPOSURE. UNIT POWER UP AND PASSES ALL FUNCTIONAL TESTS. NOTE: THE IFU HAS A WARNING STATEMENT: THE POSEY KEEPSAFE DELUXE IS AN ELECTRONIC DEVICE. IT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED, OR IMMERSED IN LIQUID. TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SVC WITH A PT, AND EACH TIME BEFORE LEAVING THE PT UNATTENDED. USE OF MIXED BATTERIES INSTALLED INCORRECTLY MAY CAUSE BATTERY DAMAGE, AND MAY DAMAGE THE ALARM. REMOVE ANY ALARM FROM USE AND SEND TO THE APPROPRIATE FACILITY AUTHORITY IF BATTERIES ARE DAMAGED OR CORRODED OR THE BATTERY COMPARTMENT HAS SIGNS OF PREVIOUS BATTERY CORROSION SUCH AS WHITE POWDER RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAVE BEEN USING THE ALARM WITH THE ORIGINAL BATTERIES FOR ONLY A MONTH. THE ALARM NOW HAS BATTERY LEAKAGE AND CORROSION. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI