BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEC 850

    MDR report key: 8573188 · Received May 2, 2019

    Report

    Report Number
    2112667-2019-00183
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 2, 2019
    Report Date
    June 7, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    PMA / PMN Number
    K172702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. LOW AGENT OUTPUT WAS REPORTED IN TESTING AT THE CUSTOMER SITE, AND ALTHOUGH IT WAS CONFIRMED THAT THIS EFFICACY TESTING WAS PERFORMED ON A NON-GE (MINDRAY) ANESTHESIA MACHINE, THE VAPORIZER WAS RETURNED TO GE HEALTHCARE FOR FURTHER TESTING. THE VAPORIZER WAS TESTED BY GE HEALTHCARE PRODUCT ENGINEERING AND FOUND AGENT OUTPUT TO BE WITHIN SPECIFICATION. THERE IS NO EVIDENCE OF A MALFUNCTION OR DEFECT OF THIS VAPORIZER. THE INVESTIGATION DETERMINED THAT THE CUSTOMER USED THIS VAPORIZER OUTSIDE OF ITS INTENDED USE ON A NON-GE (MINDRAY) ANESTHESIA MACHINE. THIS CAUSED IMPROPER SEALING OF THE VAPORIZER. THIS VAPORIZER IS DESIGNED AND MITIGATED FOR PROPER SEALING TO A GE HEALTHCARE SELECTATEC MANIFOLD ONLY. THE TEC 820/850 USER'S REFERENCE MANUAL STATES EXPLICITLY THAT "THE VAPORIZERS ARE NOT DESIGNED TO BE USED ON ANY OTHER MANUFACTURER'S ANESTHESIA MACHINE." THE ROOT CAUSE WAS DETERMINED TO BE IMPROPER USE OUTSIDE OF ITS INTENDED USE ON A NON-GE ANESTHESIA MACHINE. THE PATIENT RECOVERED AFTER THIS EVENT.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO PATIENT INFORMATION AVAILABLE AT TIME OF MDR FILING. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE FIRST USE OF THIS VAPORIZER TOWARD THE END OF THE CASE, THE PATIENT EXPERIENCED HYPERTENSION AND CODED. THE PATIENT WAS STABILIZED AND IS REPORTED TO BE ALRIGHT NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368703 TEC 850 VAPORIZER CAD DATEX-OHMEDA, INC. 1177-9850-SEV

    Patients

    Seq Age Sex Outcome Treatment
    1