BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WM CLARIS CPU

    MDR report key: 12490826 · Received September 17, 2021

    Report

    Report Number
    2184149-2021-00287
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQK
    UDI-DI
    05415067009777
    PMA / PMN Number
    K151911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE 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. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    MANUFACTURER REPORT NUMBERS: 2184149-2021-00286, 2184149-2021-00288. DURING THE PROCEDURE, AFTER BOOTING ON THE SYSTEM, PACING WAS PERFORMED AND SUCCESSFUL MEASUREMENT AND PATIENT DIAGNOSIS WAS DONE. AFTER PRESSING THE ABLATION BUTTON, A HARDWARE MALFUNCTION MESSAGE APPEARED ON THE SYSTEM MONITORING SCREEN: "NMI: PARITY CHECK / MEMORY PARITY ERROR. THE SYSTEM HAS HALTED" AND THE SYSTEM COULD NOT OPERATE AS INTENDED. THE DWS AND THE CPU WERE RESTARTED, BUT THE ISSUE PERSISTED. AFTER OVERALL PATIENT CONDITION ASSESSMENT, IT WAS DECIDED TO STOP THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES TO THE PATIENT DUE TO THESE ISSUES. PRODUCT REPLACEMENT IS NOT POSSIBLE FOR THIS CUSTOMER, SO NO EQUIPMENT WILL BE RETURNING FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384500 WM CLARIS CPU COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL H700977 5607961 05415067009777

    Patients

    Seq Age Sex Outcome Treatment
    1