BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE VELOCITY¿ DWS7 DISPLAY WORKSTATION

    MDR report key: 16338699 · Received February 9, 2023

    Report

    Report Number
    2184149-2023-00024
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 5, 2023
    Report Date
    February 9, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K202066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING AN AF PROCEDURE, IT WAS NOTED THAT THERE WERE CONNECTIONG ISSUES WITH THE ENSITE DWS RESULTING IN MULTIPLE RESTARTS WHICH CAUSED DELAYS IN TREATMENT. IT WAS NOTED THAT THE ENSITE DWS WAS UNABLE TO BOOT UP AND THERE WAS A FLASHING RED LIGHT. THE DWS WOULD CLOSE WITHOUT PROMPT ABOUT 15 SECONDS AFTER THE START BUTTON WAS PRESSED. THE DWS WAS RESTARTED AT LEAST FIVE TIMES, BUT THE ISSUE PERSISTED. CABLING WAS CHECKED, AND IT WAS DISCOVERED THAT IF THE HDMI CABLE WAS UNPLUGGED, THE DWS WAS ABLE TO BOOT. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004880 ENSITE VELOCITY¿ DWS7 DISPLAY WORKSTATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. 100129557

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown