BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7872467 · Received September 13, 2018

    Report

    Report Number
    8010042-2018-00482
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    September 5, 2018
    Report Date
    February 5, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003 GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470 CONTACT PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). REF. EXEMPTION #: E2018003. (B)(4). THE HOSPITAL BIOMEDICAL ENGINEER WAS ADVISED TO REPLACE THE NOZZLE UNIT IN THE FRESH GAS AIR GAS MODULE. THE REPLACED PART WAS NOT RETURNED FOR INVESTIGATION SINCE THE CUSTOMER DISCARDED IT. THE LOGS WERE DOWNLOADED. THE LOGS CONFIRM THE ALARMS FOR LOW FIO2 AND OTHER CLINICAL ALARMS INDICATING LEAKAGES AND DIFFICULTIES TO VENTILATE THE PATIENT AT SOME OCCASIONS DURING THE CASE. WE HAVE NOT WITH CERTAINTY BEEN ABLE TO DETERMINE THE TRUE CASE OF THE REPORTED ISSUES. IT IS HOWEVER, BASED ON THE REPORTED NOISE FROM THE FLOW-I AND THE REPLACED PART, LIKELY THAT THE NOZZLE UNIT IN THE AIR GAS MODULE OSCILLATED AT SOME OCCASIONS AND THUS DECREASED THE OXYGEN CONCENTRATION IN THE INSPIRED PATIENT GAS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE ANESTHESIA WORKSTATION GENERATED ALARMS FOR LOWER FIO2 THAN SET. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713511 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1