BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 14884678 · Received July 1, 2022

    Report

    Report Number
    2112667-2022-01949
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 6, 2022
    Report Date
    July 1, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 COMMUNICATION CABLE BETWEEN THE DAQ-POWER BOARD, THE DISPLAY UNIT, AND THE DISPLAY UNIT AND THE DAQ-PWR BOARD HAVE BEEN REPLACED TO RESOLVE THE ISSUE. 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. LEGAL MANUFACTURER: HCS (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291692 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown