BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 10178366 · Received June 22, 2020

    Report

    Report Number
    2112667-2020-01781
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    May 21, 2020
    Report Date
    June 22, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AFTER PHONE CALLS TO THE CUSTOMER 06/15/2020, 06/17/2020, AND 06/18/2020. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A MALFUNCTION RESULTING IN THE LOSS OF MECHANICAL VENTILATION. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643398 AESTIVA 7900 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1006-9305-000

    Patients

    Seq Age Sex Outcome Treatment
    1