BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 620

    MDR report key: 9915738 · Received April 2, 2020

    Report

    Report Number
    9710602-2020-00118
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 4, 2020
    Report Date
    April 2, 2020
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    BSZ
    PMA / PMN Number
    K151570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS CASE IS AN OUT OF BOX FAILURE (OBF). THERE WAS NOT A REPORTABLE MALFUNCTION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS CASE IS AN OUT OF BOX FAILURE (OBF). THERE WAS NOT A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. 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. UNIQUE IDENTIFIER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A MALFUNCTION CAUSING A LOSS OF SUCTION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379534 CARESTATION 620 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)

    Patients

    Seq Age Sex Outcome Treatment
    1