BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I-C20

    MDR report key: 8597215 · Received May 9, 2019

    Report

    Report Number
    8010042-2019-00314
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 17, 2019
    Report Date
    June 25, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THIS MATTER CONSISTS OF AN EVALUATION OF THE RECEIVED DEVICE LOGS ONLY AS WE HAVE NOT RECEIVED ANY INFORMATION IF ANY PARTS HAVE BEEN REPLACED. 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 TREND LOG CONFIRMS THE HIGH FIO2 READINGS. ALARMS FOR HIGH FICO2 LEVEL WERE GENERATED DURING ONGOING PATIENT TREATMENT. THE LOGS SHOW FURTHER THAT ALARMS FOR HIGH RESPIRATORY RATE, EXPIRATORY MINUTE VOLUME: LOW AND LEAKAGE WERE GENERATED. THE LOGS ALSO SHOW THAT THE CO2 ABSORBER WAS UN-DOCKED AND RE-DOCKED SEVERAL TIMES BY THE USER, MOST LIKELY IN UNSUCCESSFUL ATTEMPTS TO SOLVE THE HIGH FICO2 READINGS. WITHOUT ANY ADDITIONAL INFORMATION OR PARTS TO INVESTIGATE, WE ARE UNABLE TO DETERMINE THE TRUE CAUSE OF THE REPORTED ISSUES. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. (B)(4).

    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). H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION MEASURED A HIGHER FICO2 LEVEL THAN EXPECTED DURING AN EXTENDED TIME PERIOD. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387822 FLOW-I-C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1