BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20 ANESTHESIA SYSTEM

    MDR report key: 23345380 · Received October 21, 2025

    Report

    Report Number
    8010042-2025-0001562
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 21, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K191027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS OPENED IS BASED ON THAT THE CUSTOMER IN A PRIOR COMPLAINT MENTIONED THAT A SIMILAR EVENT WITH A DIFFERENT ANESTHESIA SYSTEM IN THE SAME ROOM HAD OCCURRED . THE FIRST COMPLAINT WAS REPORTED WITH MFG REPORT NUMBER 8010042-2025-0001560. NO FURTHER INFORMATION HAS BEEN GIVEN BY THE CUSTOMER. WITHOUT ADDITIONAL INFORMATION SUCH AS DEVICE SERIAL NUMBER, DATE AND TIME OF THE EVENT AND A PROPER PROBLEM DESCRIPTION, NO INVESTIGATION HAS BEEN POSSIBLE TO PERFORM. WE HAVE NOT BEEN ABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE SERIAL NUMBER OF THE DEVICE HAS NOT YET BEEN GIVEN.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH PRESSURE ALARMS WERE GENERATED DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451757 FLOW-I C20 ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6888520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown