BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE NO POWER SWITCH

    MDR report key: 2221735 · Received August 17, 2011

    Report

    Report Number
    2020362-2011-00265
    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). RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT THERE IS CORROSION ON THE BATTERY CONTACTS AND SPRINGS. THE ALARM POWERED UP AND PASSED ALL FUNCTIONAL TESTS. NOTE: POSEY'S IFU WARNING STATEMENT FOR BATTERY INSTALLATION: TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES WHEN THE CHIRPING DUE TO LOW BATTERY POWER SOUND BEGINS. DO NOT REPLACE A SINGLE CELL, BUT ALL THE CELLS IN THE ALARM. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK (4 BATTERIES). USE OF MIXED BATTERIES OR BATTERIES INSTALLED INCORRECTLY MAY CAUSE BATTERY DAMAGE, AND MAY DAMAGE THE ALARM. DO NOT USE THE ALARM IF ANY EVIDENCE OF BATTERY ACID IS NOTED IN THE BATTERY COMPARTMENT. MFR REFERENCES FILE # (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