BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 8416456 · Received March 13, 2019

    Report

    Report Number
    8010042-2019-00155
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    February 19, 2019
    Report Date
    August 22, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    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 PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THIS MATTER CONSISTS OF AN EVALUATION OF THE RECEIVED DEVICE LOGS ONLY AS THE REPLACED OXYGEN GAS MODULE NOZZLE UNITS (FRESH GAS AND REFLECTOR MODULES) HAVE NOT BEEN AVAILABLE FOR INVESTIGATION. THE LOGS WERE RECEIVED AND SHOW THAT SUCCESSFUL SYSTEM CHECK OUTS WERE PERFORMED PRIOR TO AND AFTER THE EVENT INDICATING THAT NO TECHNICAL MALFUNCTIONS WERE PRESENT. THE RECEIVED LOGS CONTAIN ALARMS FOR LOW FIO2 AND AIRWAY PRESSURE:HIGH. NO TECHNICAL ERRORS IN THE TECH LOG RELATED TO THE REPORTED EVENT CAN BE SEEN. WITHOUT HAVING BEEN ABLE TO INVESTIGATE THE REPLACED PARTS, WE ARE UNABLE TO DETERMINE THE TRUE CAUSE OF THE REPORTED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE ANESTHESIA WORKSTATION GENERATED ALARMS FOR HIGH AIRWAY PRESSURE. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF #: 1910MCC1011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208481 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1