BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 620

    MDR report key: 19298176 · Received May 13, 2024

    Report

    Report Number
    9710602-2024-00688
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 13, 2024
    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

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE FLOW SENSOR WAS RECOMMENDED FOR REPLACEMENT TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS WUXI - NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE CHINA WUXI JIANGSU, 214028

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450405 CARESTATION 620 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown