BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS

    MDR report key: 8008788 · Received October 26, 2018

    Report

    Report Number
    2112667-2018-02126
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    September 3, 2018
    Report Date
    November 7, 2018
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MANUFACTURER: CORRECTED FROM 09/03/2018 TO 10/16/2018. DATE RECEIVED BY MANUFACTURER: CORRECTED FROM 09/03/2018 TO 10/16/2018.

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPLACED THE VENTURE UNIT AND FILTER. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE SUCTION WAS NOT FUNCTIONING AS EXPECTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850689 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1