BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS CS2

    MDR report key: 9878565 · Received March 25, 2020

    Report

    Report Number
    2112667-2020-00911
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 25, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K132530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DECLINED GE HEALTHCARE REPAIR. NO FURTHER INFORMATION AVAILABLE. REQUESTED PATIENT INFORMATION VIA PHONE CALL ON 03/23/2020, 03/24/2020, AND 03/25/2020. NO PATIENT INFORMATION PROVIDED TO DATE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT RAN OUT OF ANESTHETIC AGENT RESULTING IN THE LIGHT ANESTHESIA. THERE WAS NO REPORT OF PATIENT INJURY OR RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342244 AISYS CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1011-9050-000

    Patients

    Seq Age Sex Outcome Treatment
    1