BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 1894854 · Received November 5, 2010

    Report

    Report Number
    2020362-2010-00339
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    October 12, 2010
    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

    (B)(4): EVALUATION RESULTS - EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS POWER, BUT THE ALARM TONE IS INTERMITTENT WHEN PRESSURE IS OFF THE SENSOR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS POWER, BUT WILL NOT ALARM. THE CUSTOMER HAS REPLACED THE BATTERIES AND DOES NOT DETECT ANY VISIBLE DAMAGE TO THE WIRES OR ALARM CASE. THERE WAS NO PT INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITTER II KMI J. T. POSEY CO. 8281 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SQUARE CHAIR SENSOR PAD:| OVER-THE-MATTRESS SENSOR PAD:| MODEL #: 8308, LOT # UNK| MODEL # 8307, LOT # UNK