BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 2190691 · Received July 29, 2011

    Report

    Report Number
    2020362-2011-00240
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    June 14, 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
    MA, 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 AT ONE HINGE AND HAD TO BE PRIED OPEN, THE LIQUI-LABEL IS MISSING. THE POWER BUTTON IS TORN. THE ALARM POWERED ON WITH NEW BATTERIES BUT DOES NOT SOUND. THE FAIL SAFE FEATURE DID NOT SOUND. THE LCD DISPLAY IS PARTIAL. FURTHER INVESTIGATION FOUND THAT THE SPEAKER IS BROKEN OUT OF ITS MOUNT AND ONE WIRE IS BROKEN OFF. THE DISPLAY CONNECTOR IS BROKEN OFF THE BACK OF THE DISPLAY BOARD AND FELL OFF. NOTE: POSEY INSTRUCTIONS FOR USE STATES: 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 VOLUME OF THE ALARM WILL NO INCREASE WHEN SELECTED. THE CUSTOMER HAS REPLACED THE BATTERIES AND THE OUTCOME IS THE SAME AND THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THIS WAS DISCOVERED DURING SET-UP PRIOR TO PLACING IT INTO USE WITH A PT.

    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 LOT NUMBER UNK| OVER-THE-MATTRESS SENSOR: MODEL 8307