BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20 ANESTHESIA SYSTEM

    MDR report key: 18204376 · Received November 24, 2023

    Report

    Report Number
    8010042-2023-02271
    Event Type
    Malfunction
    Date Received
    November 24, 2023
    Date of Event
    August 17, 2023
    Report Date
    November 24, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    UDI-DI
    07325710010617
    PMA / PMN Number
    K191027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRECTION OF FIELD # D1 BRAND NAME, # D4 VERSION OR MODEL #, # D4 UNIQUE IDENTIFIER (UDI) # AND H4 MANUFACTURER DATE WERE REQUIRED. D1 ¿ BRAND NAME - PREVIOUS BRAND NAME: FLOW-I C20, CORRECTED BRAND NAME: FLOW-I C20 ANESTHESIA SYSTEM. D4 ¿ VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: 6677200, CORRECTED VERSION OR MODEL #: 6888520. D4 ¿ UNIQUE IDENTIFIER (UDI) # - PREVIOUS UNIQUE IDENTIFIER (UDI) #: MISSING, CORRECTED UNIQUE IDENTIFIER (UDI) #: (B)(4). H4 ¿ MANUFACTURE DATE - PREVIOUS MANUFACTURING DATE: 210315, CORRECTED MANUFACTURING DATE: 210305.

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED BY FIELD SERVICE ENGINEER. THE CLAIMED ISSUE WAS REPRODUCED DURING TROUBLESHOOTING. ACCORDING TO RECEIVED INFORMATION, THE REPLACEMENT OF THE FRESH GAS PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD SOLVED THE ISSUE. THE SYSTEM CHECKOUT PASSED SUCCESSFULLY. THE PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD IS PART OF THE PRESSURE MEASURING IN THE SYSTEM. A FAULTY PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD MAY LEAD TO INACCURACY IN PRESSURE MEASUREMENT. THIS WILL BE DETECTED DURING SYSTEM CHECKOUT AND HIGH PRIORITY ALARMS WILL BE GENERATED IF THE FAILURE OCCURS DURING TREATMENT. THE CLAIMED PRESSURE TRANSDUCER TEST FAILURE WAS NOT CONFIRMED IN DEVICE'S LOG ON PROVIDED DATE OF EVENT. THE CAUSE OF THE CLAIMED ISSUE IN THIS CUSTOMER PRODUCT COMPLAINT HAS BEEN DETERMINED. THE ISSUE WAS RELATED TO THE FRESH GAS PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSURE TRANSDUCER TEST FAILED DURING SYSTEM CHECKOUT, THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218890 FLOW-I C20 ANESTHESIA SYSTEM GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB 6888520 07325710010617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown