BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABSYSTEM PRO

    MDR report key: 23311176 · Received October 16, 2025

    Report

    Report Number
    2124215-2025-70846
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRQ
    UDI-DI
    08714729884897
    PMA / PMN Number
    K152693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERROR MESSAGE APPEARED AT STARTUP INDICATING THE AMPLIFIER WAS NOT FUNCTIONING. SUBSEQUENTLY THE PROCEDURE WAS CANCELLED, AND IT IS UNKNOWN IF SEDATION WAS PERFORMED. DURING PREPARATION FOR A PROCEDURE, A LABSYSTEM PRO WAS SELECTED FOR USE. UPON START-UP AN ERROR DISPLAYED INDICATING THE SYSTEM WAS CONFIGURED TO USE THE AMPLIFIER, BUT IT WAS NOT FUNCTIONING PROPERLY. THE AMPLIFIER WAS RESTARTED, AND AN ORANGE LED BEGAN BLINKING. THE CABLES WERE DISCONNECTED AND RECONNECTED, AND THE SYSTEM WAS RESTARTED AGAIN WITHOUT RESOLVE. NEXT THE ETHERNET CABLE WAS REPLACED, AND THE SYSTEM WAS REBOOTED ONCE MORE. AS THE ISSUE COULD NOT BE RESOLVED, THE PROCEDURE WAS CANCELLED. IT IS UNKNOWN IF SEDATION WAS PERFORMED. THE DEVICE WAS REPAIRED ON SITE AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2664495 LABSYSTEM PRO AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC CORPORATION M00420020220 1F457441 08714729884897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown