BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WM CLARIS CPU

    MDR report key: 14015857 · Received April 5, 2022

    Report

    Report Number
    2184149-2022-00093
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 23, 2022
    Report Date
    June 9, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067009777
    PMA / PMN Number
    K151911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CLARIS DISPLAY WORKSTATION (DWS) Z440 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE FRONT PANEL PORTS, CHASSIS, AND LABELS WERE FREE OF PHYSICAL DAMAGE. POWER WAS APPLIED TO THE DWS, AND THE DWS WOULD NOT BOOT. THE MONITORS WOULD NOT FUNCTION AND NO SPLASH SCREEN WAS OBSERVED. OVER TIME THE FANS INCREASED TO MAXIMUM, BUT NO OTHER OUTPUT SIGNALS HAPPENED. BASED ON REPLACEMENT PARTS THIS SYMPTOM WAS ISOLATED TO THE MOTHERBOARD. 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 INVESTIGATION AND INFORMATION PROVIDED TO ABBOTT, THE REPORTED EVENT WAS CONFIRMED, AND THE ROOT CAUSE WAS ATTRIBUTED TO THE MOTHERBOARD.

    Description of Event or Problem · 0

    DURING DEVICE PREPARATION FOR THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, WHILE THE PATIENT WAS PREPPED, THE WORKMATE CLARIS WAS POWERED ON AND THERE WAS NO DISPLAY WHICH CAUSED A DELAY. THE CONVERSION CABLE BETWEEN THE DISPLAY AND DVI WAS REPLACED, THE DVI CABLE WAS REPLACED, THE CONNECTIONS WERE CHECKED, THE RECEPTION SETTINGS WERE CHECKED, THE DWS WAS RESTARTED AND DISCHARGED, BUT THE ISSUE PERSISTED. THE WORKMATE CLARIS WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341667 WM CLARIS CPU COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700977 6494622 05415067009777

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown