BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 620

    MDR report key: 7933824 · Received October 4, 2018

    Report

    Report Number
    2112667-2018-01942
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 4, 2018
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K151570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GE HEALTHCARE RECOMMENDED REPLACEMENT OF THE FLOW SENSOR.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT HAD A FAILURE OF THE FLOW SENSOR THAT AFFECTED MECHANICAL VENTILATION. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774305 CARESTATION 620 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1