BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 650

    MDR report key: 6810539 · Received August 22, 2017

    Report

    Report Number
    9710602-2017-00204
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 22, 2017
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    BSZ
    PMA / PMN Number
    K151570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING GE HEALTHCARE SYSTEM CHECKOUT, IT WAS NOTED THAT THE DISPOSABLE CO2 CANISTER (LOT 9170217) WAS APPROXIMATELY 1 MM SHORTER IN HEIGHT THAN A REUSABLE CANISTER. REPLACED CUSTOMER SUPPLIED DISPOSABLE CO2 CANISTER FROM LOT 3160517 TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING PATIENT USE, THE CO2 LEVEL WENT UP. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591631 CARESTATION 650 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)

    Patients

    Seq Age Sex Outcome Treatment
    1