BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3886459 · Received April 10, 2014

    Report

    Report Number
    2020362-2014-00133
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Report Date
    January 31, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT CONFIRMED THAT THE NURSE CALL RECEPTACLE IS BROKEN AND HAS A LOOSE CONNECTION. THE NURSE CALL LED FUNCTIONS WHEN TESTED, BUT IF THE NURSE CALL CABLE IS MOVED, THE NURSE CALL WILL TURN ON AND OFF.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE NURSE CALL OUTLET TO THE ALARM IS BROKEN. CUSTOMER REPORTED ISSUE WAS DISCOVERED DURING SET-UP BUT A DATE WAS NOT PROVIDED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216641 SITTER ELITE KMI J. T. POSEY COMPANY 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CHAIR SENSOR: PART # 8309, LOT # UNK