BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER ELITE

    MDR report key: 4180369 · Received October 15, 2014

    Report

    Report Number
    2020362-2014-00337
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 6, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE AND CUSTOMER NOTE: WILL NOT PLACE A CALL WITH 1/4 INCH CABLE. THE UNIT DOES NOT SEND A SIGNAL TO ACTIVATE THE RED LED AT THE NURSE CALL TEST FIXTURE WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD. THE UNIT DOES NOT SWITCH MODES BETWEEN VOICE AND MUTE MODES WHEN THE NURSE CALL CABLE IS CONNECTED TO THE SENSOR RECEPTACLE; AS A RESULT, VOICE AND MUTE TESTING COULD NOT BE DETERMINED. THE NURSE CALL RECEPTACLE HAS A CRACK IN IT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE NURSE CALL POT IS NOT SENDING A SIGNAL TO THE NURSE'S STATION. THE NURSE CALL CABLE WAS TESTED ON OTHER ALARMS AND WORKED PROPERLY. THE ISSUE WAS DISCOVERED DURING SET UP, BUT THE DATE IS UNK. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655749 POSEY SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CHAIR SENSOR, SQUARE, 30-DAY, MODEL 8309, LOT# UNK