BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 18567860 · Received January 23, 2024

    Report

    Report Number
    2112667-2024-00479
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    December 28, 2023
    Report Date
    January 23, 2024
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE DATA ACQUISITION (DAQ) BOARD WAS REPLACED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718. H3 OTHER TEXT : THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE DATA ACQUISITION (DAQ) BOARD WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF POWER AND SUBSEQUENT LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316747 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown