BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 3250326 · Received July 24, 2013

    Report

    Report Number
    2020362-2013-00329
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Report Date
    June 5, 2013
    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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; THE ALARM DID NOT POWER UP WHEN USING NEW BATTERIES, AN EXTERNAL POWER SUPPLY OR A 9V ADAPTER. HOWEVER, THERE IS A BATTERY LEAKAGE RESIDUE ON THE BATTERY COMPARTMENT WALLS AND THE AQUALERT WATER INDICATOR LABEL SHOWS EXPOSURE TO MOISTURE. NO VISIBLE CORROSION TO THE FLAT BATTERY CONTACTS OR BATTERY SPRINGS. NO FUNCTIONAL TESTS COULD BE PERFORMED SINCE THE UNIT DID NOT POWER ON. NOTE: POSEY INSTRUCTIONS FOR USE HAS A STATEMENT: IF THE ALARM IS SUBJECTED TO SEVERE MECHANICAL SHOCK, SUCH AS DROPPING, OR IS SUBMERGED IN LIQUID, IT MAY STOP FUNCTIONING AS DESIGNED. VISUALLY INSPECT THE UNIT FOR CRACKS IN THE CASE, MISSING SCREWS, MISSING BATTERY DOOR, BROKEN WIRES OR SIGNS OF EXPOSURE TO LIQUID. AFTER EACH INCIDENT, YOU MUST VERIFY THAT THE UNIT IS WORKING PROPERLY. CHECK TO MAKE SURE THE AUDIBLE ALARM IS FUNCTIONING PROPERLY BY APPLYING AND LIFTING WEIGHT OFF SENSOR IN SEVERAL SPOTS TO ACTIVATE THE ALARM. DO NOT USE IF THE AUDIBLE ALARM DOES NOT SOUND. 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 NO REPLACE A SINGLE CELL, BUT ALL 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. 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 POWER RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM HAS NO POWER. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY AND WERE INSERTED CORRECTLY. CUSTOMER REPORTED THERE IS A BURNING SMELL COMING FROM THE BATTERY COMPARTMENT. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344746 KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER-THE-MATTRESS SENSOR PAD: MODEL 8307, LOT UNK