BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO U VENTILATOR

    MDR report key: 19104355 · Received April 12, 2024

    Report

    Report Number
    MW5153818
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    April 10, 2024
    Report Date
    April 10, 2024
    Manufacturer
    GETINGE GROUP LOGISTICS AMERICA, LLC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT IS INTUBATED ON A SERVO U VENTILATOR. SERVO U BEGAN TO ALARM FLASHING A HIGH PRIORITY ALARM. THE ALARM WAS "TECHNICAL ERROR 55". THE PATIENT HAD TO BE REMOVED FROM THE VENTILATOR AND BAGGED WITH A BAG VALVE MASK. ANOTHER VENTILATOR HAD TO BE SECURED, SET UP, AND THE PATIENT WAS PLACED ON IT. THIS HAS OCCURRED WITH THIS EXACT VENTILATOR PREVIOUSLY. THE SERVICE REPRESENTATIVE CAME OUT PREVIOUSLY AND CLEARED THE VENTILATOR PROVIDING A WRITTEN REPORT THAT IT WAS SAFE TO USE ON PATIENTS. THIS HAS OCCURRED ON FOUR OCCASIONS. REFERENCE REPORT #MW5153819, #MW5153820, #MW5153821.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024408 SERVO U VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK GETINGE GROUP LOGISTICS AMERICA, LLC SERVO U

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention