BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C30

    MDR report key: 8178681 · Received December 19, 2018

    Report

    Report Number
    8010042-2018-00680
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 17, 2018
    Report Date
    May 14, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 (B)(4). CONTACT PERON: (B)(4). THE INVESTIGATION INTO THIS MATTER CONSISTS OF AN EVALUATION OF THE RECEIVED DEVICE LOGS ONLY AS NO PARTS HAVE BEEN REPORTED AS REPLACED. THE RECEIVED LOGS CONFIRM THE REPORTED ISSUE WITH HIGH FICO2 READINGS. A SUCCESSFUL SCO WAS PERFORMED PRIOR TO THE EVENT INDICATING THAT NO TECHNICAL MALFUNCTIONS WERE PRESENT. ALARMS FOR HIGH FICO2 LEVEL WERE GENERATED DURING ONGOING PATIENT TREATMENT. THE LOGS SHOW FURTHER THAT THE CO2 ABSORBER WAS REPLACED DURING THE CASE AND THAT THE USER ALSO TRIED TO RECTIFY THE ISSUE BY INCREASING THE FRESH GAS FLOW AND ACTIVATE THE O2 FLUSH SEVERAL TIMES WITHOUT SUCCESS. THE RECEIVED TREND LOG CONFIRMS THE HIGH FIO2 READINGS. WE HAVE NOT BEEN ABLE TO DETERMINE THE TRUE CAUSE OF THE REPORTED ISSUES.

    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).

    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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017013 FLOW-I C30 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C30

    Patients

    Seq Age Sex Outcome Treatment
    1