BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGSTROM

    MDR report key: 20847143 · Received December 4, 2024

    Report

    Report Number
    2112667-2024-06480
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 6, 2024
    Report Date
    December 4, 2024
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K140575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE ELECTRONIC FLOW CONTROL (EFC) VALVE WAS REPLACED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. BLOCK D4: NO UDI AVAILABLE AS DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT OXYGEN OR FRESH GAS FLOW. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942786 ENGSTROM VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown