BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2914850 · Received December 7, 2012

    Report

    Report Number
    2020362-2012-00672
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 16, 2012
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REPORTED ISSUE OF NO POWER AND LEAKAGE IS CONFIRMED. THERE IS BATTERY ACID LEAKAGE AND CORROSION ON A FLAT CONTACT AND THE AQUALERT WATER INDICATOR LABEL SHOWS MOISTURE EXPOSURE DUE TO THE BATTERY LEAKAGE. THE UNIT DID NOT POWER UP WHEN USING NEW BATTERIES. HOWEVER, UNIT DOES POWER UP WHEN USING A 9V ADAPTER OR AN EXTERNAL POWER SUPPLY AND PASSES ALL FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE STATE: 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 CELLS IN THE ALARM. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK. USE OF MIXED BATTERIES OR 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

    CUSTOMER REPORTED THAT THE UNIT WILL POWER ON. THEY HAVE REPLACED BATTERIES WITH A NEW SUPPLY. THEY DID SEE BATTERY LEAKAGE IN THE BATTERY COMPARTMENT. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED AND NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SQUARE CHAIR PAD SENSOR PART #8308, LOT #UNK