BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESTATION 650

    MDR report key: 14142974 · Received April 19, 2022

    Report

    Report Number
    2112667-2022-00926
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    March 21, 2022
    Report Date
    August 11, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K151570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. NO PATIENT INFORMATION PROVIDED TO DATE. UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    LEAKAGE POTENTIALLY OCCURRED FROM THE DEVICE OR THE BREATHING CIRCUIT. HOWEVER, AS NO FAILURE WITH THE DEVICE WAS FOUND AND THE CUSTOMER DID NOT HAVE ACCESS TO THE BREATHING CIRCUIT, THE LEAKAGE SOURCE COULD NOT BE IDENTIFIED. BASED ON AVAILABLE INFORMATION, THE ROOT CAUSE OF THE PATIENT DESATURATION WAS UNDETERMINED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT WAS CONNECTED TO A CARESTATION 650 WHEN THE UNIT WAS SUSPECTED TO LEAK OXYGEN DURING VENTILATION. REPORTEDLY, THE PATIENT DESATURATED. OXYGEN WAS INCREASED AND PATIENT OXYGEN SATURATION LEVEL RETURNED TO NORMAL. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935065 CARESTATION 650 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1012-9650-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention