BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I

    MDR report key: 11930095 · Received June 3, 2021

    Report

    Report Number
    8010042-2021-01278
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 3, 2021
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANESTHESIA SYSTEM WAS INVESTIGATED AT THE HOSPITAL BY OUR COMPANY FIELD SERVICE ENGINEER. ACCORDING TO THE SERVICE REPORT, FOUR PRESSURE REGULATORS IN THE DIVE GAS SUPPLY SECTION WERE DAMAGED BY WATER INFILTRATION FROM THE MEDICAL AIR LINE. REPLACEMENT OF PRESSURE REGULATORS SOLVED THE REPORTED ISSUE. SUCCESSFUL CALIBRATIONS AND FUNCTIONAL TESTS WERE PERFORMED AND THE UNIT WAS CLEARED FOR CLINICAL USE. THE REPLACED PARTS HAVE NOT BEEN RETURNED FOR INVESTIGATION BUT BASED ON THE RECEIVED INFORMATION, THE CAUSE WAS TOO MUCH WATER IN THE SUPPLIED GAS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION HAD FAILED THE PRESSURE TRANSDUCER TEST DURING SYSTEM CHECK OUT. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER´S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827964 FLOW-I GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB FLOW-I C20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown