BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 14461650 · Received May 20, 2022

    Report

    Report Number
    2112667-2022-01248
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 22, 2022
    Report Date
    July 6, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: (B)(4).

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE DAQ BOARD, THE DISPLAY, AND THE CABLE BETWEEN THE DAQ BOARD AND DISPLAY WERE REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION DURING A CASE. THE PATIENT WAS SWITCHED TO MANUAL VENTILATION AND CASE RESUMED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583127 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown