BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7666587 · Received July 6, 2018

    Report

    Report Number
    8010042-2018-00337
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    July 2, 2018
    Report Date
    January 23, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    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). THE ANESTHESIA WORKSTATION WAS INVESTIGATED AT THE HOSPITAL BY OUR COMPANY REPRESENTATIVE. THE INVESTIGATION CONCLUDED THAT THE FRESH GAS SAFETY VALVE WAS STUCK IN OPEN POSITION AND NEEDED TO BE REPLACED. THE REPLACED FRESH GAS SAFETY VALVE WAS NOT RETURNED FOR INVESTIGATION AND IS NO LONGER AVAILABLE. THE DEVICE LOGS WERE RECEIVED AND THEY SHOW THAT THERE WERE LEAKAGES DURING THE REPORTED CASE AND ALSO DURING THE FOLLOWING SYSTEM CHECK OUTS THAT WERE PERFORMED AFTER THE EVENT. THE LEAKAGES CAUSED THE SYSTEM CHECK OUTS TO FAIL. WE HAVE NOT BEEN ABLE TO WITH CERTAINTY DETERMINE THE CAUSE OF THE ISSUE BUT IT IS LIKELY THAT THE FRESH GAS SAFETY VALVE NOT BEING ABLE TO CLOSE PROPERLY CAUSED THE EXPERIENCED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE ANESTHESIA WORKSTATION STOPPED DELIVERING GAS TO THE PATIENT. FINAL PATIENT OUTCOME WAS REPORTED TO BE NO INJURY. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510369 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1