BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE CS2

    MDR report key: 6593831 · Received May 26, 2017

    Report

    Report Number
    2112667-2017-00986
    Event Type
    Malfunction
    Date Received
    May 26, 2017
    Date of Event
    May 1, 2017
    Report Date
    May 26, 2017
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K123125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. ATTEMPTS WERE MADE AS FOLLOWS: 5/22/2017 - PHONE, 5/22/2017 - EMAIL, 5/25/2017 - EMAIL. GE HEALTHCARE RECOMMENDED TO THE HOSPITAL TO REPLACE THE CARRIER BOARD. NO FURTHER INFORMATION IS AVAILABLE REGARDING ISSUE OR RESOLUTION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CASE, THE SCREEN BLANKED OUT. THE CLINICIAN REPORTEDLY CYCLED POWER AND WAS ABLE TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375882 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1