BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2860215 · Received November 2, 2012

    Report

    Report Number
    2020362-2012-00631
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Report Date
    October 10, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULTS: EVALUATION OF THE RETURNED UNIT CONFIRMED THAT THE UNIT DOES NOT POWER UP WHEN USING NEW BATTERIES. CORROSION DUE TO BATTERY LEAKAGE WAS ALSO FOUND ON THE BATTERY SPRINGS AND FLAT CONTACTS. 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 UNIT WILL NOT POWER ON. THEY HAVE REPLACED BATTERIES WITH NEW SUPPLY. THE BATTERY SPRINGS HAVE NO CORROSION OR DAMAGE AND NO OTHER PHYSICAL DAMAGE WAS REPORTED BY THE CUSTOMER. 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