BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 16906218 · Received May 10, 2023

    Report

    Report Number
    2112667-2023-02432
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 14, 2023
    Report Date
    May 10, 2023
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 ISSUE WAS RESOLVED BY REPLACING THE EXTERNAL VAC SAX DISPOSABLE SUCTION LINER. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. BLOCK E1: THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. 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 LOSS OF SUCTION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579530 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown