BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 3000

    MDR report key: 302781 · Received October 26, 2000

    Report

    Report Number
    2112667-2000-00067
    Event Type
    Malfunction
    Date Received
    October 26, 2000
    Date of Event
    September 6, 2000
    Report Date
    October 25, 2000
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED VENTILATOR SCREEN WENT BLANK DURING CASE. THERE WAS NO REPORTED PT INJURY. RECEIPT OF INITIAL INFO - 9/6/2000. RECEIPT OF ADDITIONAL INFO - 10/20/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA 3000 ANESTHESIA MACHINE BSZ DATEX-OHMEDA AESTIVA 3000 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN