BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2462881 · Received February 3, 2012

    Report

    Report Number
    2020362-2012-00058
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Report Date
    January 17, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL CODES, RESULTS: (OTHER) - EVAL OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS INTERMITTENT POWER. THERE WAS NO EXTERNAL PHYSICAL DAMAGE TO THE UNIT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ALARM SOUNDS INTERMITTENTLY. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. CUSTOMER REPORTED THE SENSOR HAS ONLY BEEN IN USE FOR 4 MONTHS. THERE WAS NO PT INCIDENT OR INJURY 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 NI SQUARE CHAIR SENSOR PAD: MODEL 8308, LOT# UNK