BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKMATE¿ CLARIS¿ AMPLIFIER

    MDR report key: 24188416 · Received January 27, 2026

    Report

    Report Number
    2184149-2026-00011
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    December 9, 2025
    Report Date
    April 16, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQK
    UDI-DI
    05415067001696
    PMA / PMN Number
    K151911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6, H11. ONE WORKMATE¿ CLARIS¿ AMPLIFIER 56 CHANNELS WAS RECEIVED FOR EVALUATION. WHEN POWER WAS APPLIED, THE AMPLIFIER LACKED A BEEP, INDICATING AN UNSUCCESSFUL POST (POWER-ON-SELF-TEST). THE SBC (SINGLE BOARD COMPUTER) WAS TEMPORARILY REPLACED WITH A KNOWN-GOOD UNIT, WHICH POST WAS SUCCESSFULLY COMPLETED. BASED ON THE INFORMATION AND INVESTIGATION PROVIDED TO ABBOTT, THE ROOT CAUSE WAS ISOLATED TO THE SBC. THE BATCH 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

    THE ATRIAL FIBRILLATION PROCEDURE WITH RADIOFREQUENCY ABLATION WAS CANCELED. DURING THE PROCEDURE, THERE WAS NO COMMUNICATION BETWEEN THE WORKMATE CLARIS AMPLIFIER AND THE CPU. TROUBLESHOOTING INCLUDED SEVERAL RESTARTS OF THE AMPLIFIER, THE CPU, AND THE POWER SUPPLIES OF THE ETHERNET CONVERTER AND THE AMPLIFIER CART WITH NO RESOLUTION. THE POWER CABLES WERE CHECKED AND THE FIBER OPTIC CABLE WAS CHANGED WITH NO RESOLUTION. THE PROCEDURE WAS CANCELED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13021 WORKMATE¿ CLARIS¿ AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ABBOTT MEDICAL H700169 6929644 05415067001696

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown