BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 2190690 · Received July 29, 2011

    Report

    Report Number
    2020362-2011-00238
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    May 5, 2011
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT THE BATTERY DOOR IS DAMAGED ON THE OUTSIDE AND THE LIQUI-LABEL WAS MISSING. THE ALARM HAS POWER, BUT WHEN RECORDING A MESSAGE THERE IS A BEEP NOISE, ALL OTHER FUNCTIONS PASSED TESTING. WHEN THE DEVICE WAS RETESTED AT THE COMPONENT LEVEL IT WAS DISCOVERED THAT THE VOLTAGE POWERING THE SOUND AMPLIFIER VARIES CAUSING SOUND TO COME OFF AND ON WHEN PRESSURE IS OFF THE PAD. NOTE: THE POSEY SITTER II IS AN ELECTRONIC DEVICE. IT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED, OR IMMERSED IN LIQUID. STORE THE ALARM IN A SECURE PLACE SO IT WILL NOT BE DROPPED OR DAMAGED. DO NOT USE IF: BATTERY DOOR IS MISSING; BATTERY DOOR IS DAMAGED; ALARM CASE IS DAMAGED; OR ALARM CASE IS CRACKED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM HAS POWER HOWEVER; THE ALARM TONE IS INTERMITTENT WHEN PRESSURE IS OFF OF THE SENSOR PAD. THE CUSTOMER TESTED THE ALARM WITH NEW BATTERIES AND A NEW SENSOR AND THE RESULTS REMAINED THE SAME. THIS WAS DISCOVERED DURING SET UP SO THERE WAS NO PT CONTACT WITH THE PRODUCT.

    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 NA POSEY SINGLE USE CHAIR SENSOR: MODEL 8309| LOT NUMBER UNK