BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 11789385 · Received May 7, 2021

    Report

    Report Number
    2112667-2021-01201
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 7, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. ALL CABLE/HARNESS CONNECTIONS OF THE DAQ BOARD WERE RECONNECTED TO RESOLVE THE ISSUE. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. ALL CABLE/HARNESS CONNECTIONS OF THE DAQ BOARD WERE RECONNECTED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT HAD AN ERROR THAT RESULTS IN A LOSS OF MECHANICAL VENTILATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691256 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1