BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANCE

    MDR report key: 5646907 · Received May 11, 2016

    Report

    Report Number
    2112667-2016-00896
    Event Type
    Death
    Date Received
    May 11, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 5, 2018
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Additional Manufacturer Narrative · 1

    THE GE HEALTHCARE FIELD ENGINEER PROVIDED ADDITIONAL INFORMATION THAT THE REPORTED EVENT INVOLVED A NON-GE HEALTHCARE DEVICE.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE INITIAL MDR WAS SUBMITTED AS A REPORTABLE MALFUNCTION. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT INVOLVED WAS A NON-GE PRODUCT. THEREFORE, A FOLLOW-UP #1 MDR WAS SUBMITTED. CORRECTION: THE INITIAL MDR WAS SUBMITTED AS A REPORTABLE MALFUNCTION. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT INVOLVED WAS A NON-GE PRODUCT. THEREFORE, A FOLLOW-UP #1 MDR WAS SUBMITTED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT WAS NOT ABLE TO FUNCTION. NO INFORMATION REGARDING PATIENT INVOLVEMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301121 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1