BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 18037558 · Received October 31, 2023

    Report

    Report Number
    8010042-2023-02096
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 31, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    **DEVICE RELATED DATA QUALITY UPDATES ONLY** A CORRECTION OF FIELD # D1 BRAND NAME, # D4 VERSION OR MODEL #. D1 - BRAND NAME PREVIOUS BRAND NAME: SERVO-U. CORRECTED BRAND NAME: BASE UNIT SERVO-U. D4 - VERSION OR MODEL # PREVIOUS VERSION OR MODEL #: SERVO-U. CORRECTED VERSION OR MODEL #: 6694800.

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED BY OUR FIELD SERVICE ENGINEER. THE CLAIMED ISSUE WAS REPRODUCED DURING TROUBLESHOOTING. IT WAS CLARIFIED THAT DEVICE GENERATED TECHNICAL ERROR, WHICH INDICATES THAT OPEN LUNG TOOL (OLT) ABORT WAS IGNORED AND INTERRUPTION FAILED. THE SOFTWARE WAS UPDATED TO VERSION 4.4, WHICH RESOLVED THE ISSUE. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. TECHNICAL ERROR INDICATING OLT ABORT IGNORED ALARM SHALL BE TRIGGERED IF BREATHING DOES NOT ABORT AN ONGOING RM WITHIN 30±1 SECONDS AFTER RM ABORT NOTIFICATION HAS BEEN RECEIVED BY THE MONITORING SUBSYSTEM. EVALUATION OF RECEIVED DEVICE LOGS, CONFIRMED THE OCCURRENCE OF THE REPORTED ISSUE. THE ROOT CAUSE OF THE TECHNICAL ERROR ACTIVATION WAS DETERMINED AS DESIGN AS IT IS RELATED TO A BUG IN THE SOFTWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ERROR CODE. NO MORE INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: 907116.

    Description of Event or Problem · 0

    MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124730 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown