BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 620

    MDR report key: 19048235 · Received April 5, 2024

    Report

    Report Number
    9710602-2024-00467
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 4, 2024
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    BSZ
    UDI-DI
    00840682124546
    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

    THE CUSTOMER DECLINED GE SERVICE. NO REPAIR INFORMATION AVAILABLE. 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 A MALFUNCTION RESULTING IN INABILITY TO POWER UP AND SUBSEQUENT LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298394 CARESTATION 620 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) 00840682124546

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown