BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS

    MDR report key: 3140092 · Received May 29, 2013

    Report

    Report Number
    2112667-2013-00021
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT, DURING EMERGENCE AT THE END OF THE CASE, PRESSURE COULD NOT BE GENERATED IN EITHER MECHANICAL OR MANUAL MODE. THE CLINICIAN REPORTEDLY SWITCHED THE PT TO AN AMBU BAG TO MAINTAIN VENTILATION. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236592 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1