BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESTATION 650

    MDR report key: 19140069 · Received April 18, 2024

    Report

    Report Number
    9710602-2024-00542
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    March 22, 2024
    Report Date
    June 27, 2024
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    BSZ
    UDI-DI
    00840682124560
    PMA / PMN Number
    K151570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. LEGAL MANUFACTURER: HCS WUXI - NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE CHINA WUXI JIANGSU, 214028.

    Additional Manufacturer Narrative · 0

    THE END USER COMPLETED AN INVESTIGATION AND SHARED THE RESULTS WITH GE HEALTHCARE. THE ROOT CAUSE OF THE PATIENT DESATURATION WAS A USE ERROR. THE USER ERRORS WERE 1) THE BAG PORT WAS BLOCKED WITH A PLUG DURING THE DISINFECTION PROCESS AND 2) THE DEVICE WAS SET IN CHECKOUT STATE FOR MANUAL VENTILATION AND MECHANICAL VENTILATION. THERE WAS NO ISSUE WITH THE DEVICE AFTER REMOVING THE PLUG. THERE WAS NO MALFUNCTION.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT WAS CONNECTED TO A CARESTATION 650 WHEN IT WAS ALLEGED THAT THE UNIT STOPPED VENTILATING. IT WAS REPORTED THAT THE PATIENT BECAME HYPOXIC FOR 5 MINUTES, AND THAT THE PATIENT DESATURATED FROM 90% TO 70%. REPORTEDLY, THE PATIENT WAS SWITCHED TO AN AMBU BAG, AND THE UNIT WAS REPLACED DURING THE CASE. THERE WAS NO PATIENT SEQUELAE. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584264 CARESTATION 650 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) 00840682124560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other