BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 16353897 · Received February 10, 2023

    Report

    Report Number
    2112667-2023-00625
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 15, 2023
    Report Date
    February 10, 2023
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE CPU, DAQ BOARD, AND DISPLAY UNIT TO DAQ CABLE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT INFORMATION PROVIDED TO DATE AFTER CALLS TO CUSTOMER 01/30/23 AND 02/07/23. UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN UNIT SHUTDOWN AND RESTART DURING A CASE. THEIR WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996153 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1009-9212-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown