BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WM CLARIS CPU

    MDR report key: 12967353 · Received December 9, 2021

    Report

    Report Number
    2184149-2021-00401
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 23, 2021
    Report Date
    February 16, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQK
    UDI-DI
    05415067009777
    PMA / PMN Number
    K151911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 DID NOT ACHIEVE THE SPLASH SCREEN, WHICH DUPLICATES THE REPORTED SYMPTOM. THE MOTHERBOARD DID NOT BEGIN THE POWER-ON-SELF-TEST (POST), AND THUS NEVER TRIED THE SOLID STATE HARD DRIVES. BASED ON INDIVIDUAL PART REMOVAL THE ROOT CAUSE WAS ATTRIBUTED TO THE MOTHER BOARD. BASED ON THE INVESTIGATION AND INFORMATION PROVIDED TO ABBOTT, THE REPORTED EVENT WAS CONFIRMED, AND THE ROOT CAUSE WAS ATTRIBUTED TO THE MOTHER BOARD. 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.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE SYSTEM WOULD NOT BOOT UP AND THE DISPLAY WOULD NOT APPEAR ON THE MONITORS AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866002 WM CLARIS CPU COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL H700977 6796051 05415067009777

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown