BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT B MONITOR

    MDR report key: 21233146 · Received January 24, 2025

    Report

    Report Number
    3005099803-2025-00164
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 31, 2024
    Report Date
    June 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    00191506007805
    PMA / PMN Number
    K211030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6 (DEVICE CODES): PROBLEM CODE A06 CAPTURES THE REPORTABLE EVENT OF LOSS OF VISUALIZATION INSIDE THE PATIENT. BLOCK H11: THE RETURNED EXALT MODEL B MONITOR WAS ANALYZED, IT WAS FOUND THAT THE DEVICE OPERATES AS INTENDED. THE LOGS SHOWED THAT THE DEVICE SHUTDOWN BY ITSELF 8 TIMES IN THE LAST TWO YEARS AFTER THE BATTERY LEVEL DROPPED BELOW 1% WHEN THE DEVICE WAS NOT PLUGGED INTO THE POWER SUPPLY. DURING NORMAL OPERATION, THE DEVICE DISPLAYED SWITCHES TO THE SCREEN SAVER (A BLACK SCREEN WITH BOSTON SCIENTIFIC DISPLAYED IN THE MIDDLE) AFTER TWO MINUTES OF INACTIVITY, THEN AFTER THE BATTERY REACHED 1% LEVEL THE DEVICE AUTOMATICALLY SHUT DOWN. WITH ALL THE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE WAS ANALYZED AND OPERATED AS INTENDED BUT FAILED THE BATTERY HEALTH TEST. THE CAUSE OF THE REPORTED EVENT WAS TRACED TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS. THEREFORE, THE EVENT IS ASSIGNED A PROBABLE CAUSE OF FAILURE TO FOLLOW INSTRUCTIONS.

    Additional Manufacturer Narrative · 0

    BLOCK H6 (DEVICE CODES): PROBLEM CODE A06 CAPTURES THE REPORTABLE EVENT OF LOSS OF VISUALIZATION INSIDE THE PATIENT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-00165 FOR THE EXALT MODEL B SCOPE AND REPORT NUMBER 3005099803-2025-00164 FOR THE EXALT MODEL B MONITOR. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT B MONITOR WAS USED ON (B)(6) 2024. IT WAS OBSERVED THAT THE MONITOR SCREEN GOES DARK AFTER BEING POWERED ON FOR A LONG PERIOD OF TIME. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING A PATIENT INVOLVEMENT, DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-00165 FOR THE EXALT MODEL B SCOPE AND REPORT NUMBER 3005099803-2025-00164 FOR THE EXALT MODEL B MONITOR. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT B MONITOR WAS USED ON DECEMBER 31, 2024. IT WAS OBSERVED THAT THE MONITOR SCREEN GOES DARK AFTER BEING POWERED ON FOR A LONG PERIOD OF TIME. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING A PATIENT INVOLVEMENT, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140826 EXALT B MONITOR BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00542760 0022181071 00191506007805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown