BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 620

    MDR report key: 7041092 · Received November 17, 2017

    Report

    Report Number
    2112667-2017-02159
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 17, 2017
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K151570
    Removal / Correction Number
    FMI 34086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM. THE LOWER ABSORBER ASSEMBLY WAS REPLACED. THE VENTILATOR BELLOWS HOUSING WAS REPLACED. THE LOWER ABSORBER BYPASS ASSEMBLY WAS CLEANED AND THE O-RINGS WERE LUBRICATED. AN INCOMPLETE SEAL CAN EXIST BETWEEN THE DISPOSABLE ABSORBER AND THE BREATHING CIRCUIT LOWER ASSEMBLY OF THE CARESTATION 600 SERIES SYSTEMS. THIS INCOMPLETE SEAL CAN ALLOW REBREATHING OF PATIENT GASES THAT HAVE BYPASSED THE CARBON DIOXIDE (CO2) ABSORBENT MATERIAL AND COULD RESULT IN UNINTENDED ELEVATED INSPIRED LEVELS OF CO2 (FICO2), WHICH COULD LEAD TO HYPERCARBIA. GE HEALTHCARE INITIATED AND REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON OCTOBER 18, 2017. THE GEHC INTERNAL FIELD MODIFICATION NUMBER IS (B)(4). PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. ATTEMPTS WERE MADE AS FOLLOWS: 11/13/2017 PHONE CALL, 11/14/1207 PHONE CALL, 11/15/2017 PHONE CALL. UNIQUE DEVICE IDENTIFIER: (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED HIGH FICO2 READINGS. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822804 CARESTATION 620 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1012-9620-000

    Patients

    Seq Age Sex Outcome Treatment
    1