BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2860237 · Received November 2, 2012

    Report

    Report Number
    2020362-2012-00633
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Report Date
    October 11, 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

    EVALUATION RESULTS: EVALUATION OF THE RETURNED UNIT CONFIRMED THE REPORTED ISSUE OF NO POWER. UNIT DID NOT POWER UP WHEN USING NEW BATTERIES OR WHEN USING AN EXTERNAL POWER SUPPLY. THE BATTERY SPRINGS AND FLAT CONTACTS ARE CORRODED FROM BATTERY LEAKAGE. THE HOLD/SUSPEND BUTTON IS STUCK AND A PIECE OF IT'S COMING OUT FROM THE TOP OF CASE. UNIT POWERS UP WHEN USING A 9V ADAPTER. LOW BATTERY FUNCTION CANNOT BE TESTED SINCE THE 9V ADAPTER IS A FIXED VOLTAGE SOURCE. DUE TO THE CONDITION OF THE HOLD/SUSPEND BUTTON, IT CANNOT BE PRESSED AND HOLD/SUSPEND FUNCTIONS CANNOT BE TESTED AS A RESULT. THE TONE BUTTON IS NOT CHANGING THE TONES WHEN THE BUTTONS IS PRESSED. NOTE: INSTRUCTIONS FOR USE STATE: TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. BATTERIES CAN EXPLODE OR LEAK AND CAUSE DAMAGE TO ALARM IF INSTALLED INCORRECTLY, FULLY DISCHARGED, OR EXPOSED TO LIQUID, FIRE OR HIGH TEMPERATURES. IF BATTERY DAMAGE HAS OCCURRED, OR YOU SEE ANY CORROSION, REMOVE THE ALARM FORM USE IMMEDIATELY. DO NOT USE THE ALARM IF BATTERY DAMAGE HAS BEEN DETECTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ALARM HAS NOT POWER. BATTERIES HAVE BEEN REPLACED AND INSERTED CORRECTLY. THERE ARE NO SIGNS OF BATTERY LEAKAGE OR CORROSION. BATTERY SPRINGS ARE INTACT AND THE OUTSIDE OF THE UNIT HAS NOT VISIBLE DAMAGES. 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 OVER MATTRESS SENSOR PAD PART #8307, LOT # UNK