BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 10941439 · Received December 3, 2020

    Report

    Report Number
    2112667-2020-03359
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 3, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION TO DATE AFTER CALLS TO CUSTOMER 11/24/2020, 11/25/2020, AND 11/30/2020. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT CONFIRM THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED AN ERROR THAT CAUSED A LOSS OF MECHANICAL VENTILATION DURING A CASE. THE UNIT WAS REPLACED AND CASE RESUMED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407970 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1009-9212-000

    Patients

    Seq Age Sex Outcome Treatment
    1