BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3868509 · Received May 8, 2014

    Report

    Report Number
    2020362-2014-00181
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED ALARM CONFIRMED THE REPORTED ISSUE; RED LED LIGHT AT THE NURSE CALL TEST FIXTURE DOES NOT TURN ON WHEN THE NURSE CALL FEATURE IS TESTED; HOWEVER, WHEN THE NURSE CABLE IS WIGGLED, THE RED LED LIGHT TURNS ON AND OFF. VOICE ONLY AND MUTE TESTS CANNOT BE TAKEN DUE TO THE UNIT DOES NOT GO INTO VOICE ONLY AND MUTE MODES. UNIT PASSED ALL OTHER FUNCTIONS. THERE IS A RATTLING SOUND FROM INSIDE THE ALARM UNIT AND THE NURSE CALL RECEPTACLE IS DAMAGED, BUT IT STILL SECURES THE NURSE CALL CABLE. NOTE: THE INSTRUCTIONS FOR USE HAS A STATEMENT: THE POSEY SITTER ELITE IS AN ELECTRONIC DEVICE. IT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED, OR IMMERSED IN LIQUID. TO REDUCT 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, OR MAGNET IS REMOVED FROM FACE PLATE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE NURSE CALL CABLE IS INSERTED INTO THE NURSE CALL OUTLET, IT DOES NOT SEND A SIGNAL TO THE NURSE CALL STATION. CUSTOMER REPORTED IT WAS FOUND DURING SET UP BUT COULD NOT PROVIDE A DATE WHEN DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278271 SITTER ELITE KMI J. T. POSEY COMPANY 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NURSE CALL CABLE: PN 8282