BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 1894865 · Received November 5, 2010

    Report

    Report Number
    2020362-2010-00341
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    September 21, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: OTHER, EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS INTERMITTENT POWER WHEN USING NEW BATTERIES. THE ALARM CASE IS DAMAGE ON THE TOP LEFT AND BOTTOM RIGHT CORNERS. THE LIQUID LABEL IS MISSING. NOTE: POSEY INSTRUCTIONS FOR USE AS A STATEMENT: "THE ALARM IS AN ELECTRONIC DEVICE. IF THE UNIT IS SUBJECTED TO SEVERE MECHANICAL SHOCK SUCH AS DROPPING THE UNIT, OR IS SUBMERGED IN LIQUID, THE UNIT MAY STOP FUNCTIONING AS DESIGNED". (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER DID NOT PROVIDE A REASON FOR THE RETURN OF THE PRODUCT. THERE WAS NO PT INJURY REPORTED. MORE INFORMATION REC'D ON THE PRODUCT STATES "WILL NOT TURN ON". INSPECTION SHOWS THAT THE ALARM HAS INTERMITTENT POWER.

    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 DISPOSABLE BED SENSOR: MODEL #: 8283, LOT # UNK