BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 620

    MDR report key: 14135985 · Received April 18, 2022

    Report

    Report Number
    9710602-2022-00141
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 23, 2022
    Report Date
    April 18, 2022
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    BSZ
    PMA / PMN Number
    K151570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S. AND THEREFORE; THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: HCS WUXI NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE CHINA WUXI JIANGSU, 214028.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED AN ERROR THAT RESULTS IN A LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845795 CARESTATION 620 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown