BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEC 6 PLUS

    MDR report key: 2519937 · Received April 4, 2012

    Report

    Report Number
    2112667-2012-00017
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 7, 2012
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    CAD
    PMA / PMN Number
    K000275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER (B)(6) DATA PROTECTION ACT 1998, PT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE VAPORIZER WAS NOTED TO BE LEAKING AND THAT THE PT WOULD NOT WAKE UP. NO FURTHER INFORMATION COULD BE OBTAINED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 PLUS ANESTHESIA VAPORIZER CAD DATEX-OHMEDA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other