BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE VIEW

    MDR report key: 15801366 · Received November 15, 2022

    Report

    Report Number
    2112667-2022-04769
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 15, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. RESEATED THE DAQ PCB TO DISPLAY WIRING HARNESS AT BOTH THE DAQ END AND DISPLAY END TO RESOLVE THE ISSUE. NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN THE LOSS OF DISPLAY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837546 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown