BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANCE

    MDR report key: 14465391 · Received May 21, 2022

    Report

    Report Number
    2112667-2022-01264
    Event Type
    Death
    Date Received
    May 21, 2022
    Date of Event
    April 1, 2021
    Report Date
    May 18, 2023
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. AGE OR DATE OF BIRTH, WEIGHT, ETHNICITY, AND RACE: INFORMATION NOT PROVIDED. REPORT SOURCE OTHER: ATTORNEYS (B)(6). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER WERE MADE ON 26-APR-2022, 28-APR-2022, AND 04-MAY-2022. NO FURTHER INFORMATION PROVIDED TO DATE. LEGAL MANUFACTURER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE ALLEGED ISSUE DURING USE OF THE AVANCE ANESTHESIA MACHINE IS UNDETERMINED. ASIDE FROM INFORMATION PROVIDED BY THE FACILITY THAT THE BAG/VENT SWITCH WAS PURCHASED FOR REPLACEMENT AFTER THE EVENT, THE DEVICE HAS NOT BEEN INSPECTED AND THERE WAS NO INFORMATION PROVIDED AFTER MULTIPLE ATTEMPTS FROM GE HEALTHCARE TO OBTAIN ANY DETAIL OF HOW VENTILATION WAS UNAVAILABLE. H3 OTHER TEXT : THE ROOT CAUSE OF THE ALLEGED ISSUE DURING USE OF THE AVANCE ANESTHESIA MACHINE IS UNDETERMINED. ASIDE FROM INFORMATION PROVIDED BY THE FACILITY THAT THE BAG/VENT SWITCH WAS PURCHASED FOR REPLACEMENT AFTER THE EVENT, THE DEVICE HAS NOT BEEN INSPECTED AND THERE WAS NO INFORMATION PROVIDED AFTER MULTIPLE ATTEMPTS FROM GE HEALTHCARE TO OBTAIN ANY DETAIL OF HOW VENTILATION WAS UNAVAILABLE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT DEATH AFTER USE OF THE AVANCE. IT WAS REPORTED THE UNIT ALLEGEDLY FAILED? DURING SURGERY. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200669 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death