BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3040603 · Received March 12, 2013

    Report

    Report Number
    2020362-2013-00109
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. NOTE INSTRUCTIONS FOR USE STATE: THE POSEY SITTER SELECT IS AN ELECTRONIC DEVICE. IT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED, OR IMMERSED IN LIQUID. TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PATIENT, AND EACH TIME BEFORE LEAVING THE PATIENT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, THE PIR SENSOR IS ACTIVATED, OR MAGNET IS REMOVED FROM FACE PLATE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM DOES NOT SOUND. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. NO VISIBLE DAMAGE REPORTED. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104496 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SQUARE CHAIR SENSOR PART # 8308, LOT # UNK