BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 3253642 · Received July 17, 2013

    Report

    Report Number
    2020362-2013-00328
    Event Type
    Malfunction
    Date Received
    July 17, 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: EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; THE ALARM DID NOT POWER UP WHEN USING NEW BATTERIES OR AN EXTERNAL POWER SUPPLY. HOWEVER, THE ALARM DOES POWER ON WHEN USING THE 9V ADAPTER BUT DOES NOT SOUND AT ALL NO MATTER WHAT MODE THE ALARM IS SET ON. NURSE CALL LIGHT DOES NOT COME ON AT THE NURSE CALL TEST FIXTURE. NO OTHER FUNCTIONAL TESTS CAN BE PERFORMED SINCE THE ALARM DOES NOT SOUND. NO PHYSICAL DAMAGES WERE OBSERVED TO THE ALARM UNIT. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331049 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