BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 1904152 · Received November 12, 2010

    Report

    Report Number
    2020362-2010-00349
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 20, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EVAL OF THE RETURNED PRODUCT FOUND THAT THE ALARM POWERS ON BUT HAS NO ALARM TONE WHEN PRESSURE IS OFF THE PAD. THE DIFFERENT ALARM TONES ARE NOT SOUNDING. THE ALARM CASE HAS A CRACK ON THE BOTTOM RIGHT CORNER OF THE CASE. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: "THE POSEY SITTER II 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 REPORTED THAT THE ALARM HAS POWER, BUT THERE IS NO ALARM TONE WHEN PRESSURE IS OFF THE PAD. ALSO, THERE IS NO ALARM TONE WHEN THE SENSOR IS DETACHED FROM THE ALARM AND THE ALARM WILL NOT ALLOW DIFFERENT TONES TO BE SELECTED. THE CUSTOMER REPORTED THAT THERE WAS NO VISIBLE DAMAGE TO THE ALARM CASE. THERE WAS NO PT INCIDENT OR INJURY 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: MODEL 8308, LOT # UNK