BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20 ANESTHESIA SYSTEM

    MDR report key: 21812307 · Received April 10, 2025

    Report

    Report Number
    8010042-2025-0000564
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    January 22, 2025
    Report Date
    April 10, 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

    THE INVESTIGATION OF THE REPORTED FAILURE IN THIS COMPLAINT HAS BEEN COMPLETED. DEVICE LOGS WERE NOT AVAILABLE FOR REVIEW. OUR FIELD SERVICE ENGINEER INVESTIGATED THE SYSTEM ON-SITE AND CONFIRMED THE ISSUE. THE PEEP MEMBRANE IN THE PATIENT CASSETTE WAS REPLACED, WHICH INITIALLY RESOLVED THE PROBLEM. HOWEVER, THE ISSUE RECURRED AFTER TWO DAYS, PROMPTING FURTHER SERVICE INTERVENTION. AS A RESULT, THE FSE REPLACED BOTH THE INSPIRATORY PRESSURE TRANSDUCER AND THE EXPIRATORY CHANNEL PCB. THIS INCIDENT IS DOCUMENTED IN MFG REPORT NUMBER: 8010042-2025-0000211.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE MEASURED PEEP PRESSURE WAS HIGHER THAN SET. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665657 FLOW-I C20 ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6888520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown