BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 19528680 · Received June 13, 2024

    Report

    Report Number
    3013876692-2024-00030
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 3, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED BY OUR FIELD SERVICE ENGINEER (FSE). NO VENTILATOR ERRORS COULD BE DETECTED AND NO PARTS WERE REPLACED. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. EVALUATION OF THE RECEIVED LOGS REVEALED ALARMS INDICATING O2 SUPPLY LOW. MOREOVER, THE VENTILATION MODE WAS SET TO HIGH FLOW THERAPY AT DATE OF THE EVENT (SEE BELOW). 2024-05-21 20:31:25 PARAMETER CHANGE VENTILATION MODE SET TO HIGH FLOW. 2024-05-21 20:32:30 PARAMETER CHANGE O2 CONCENTRATION SET TO 35 %. 2024-05-21 20:32:36 PARAMETER CHANGE FLOW SET TO 60 L/MIN. 2024-05-21 20:35:23 PARAMETER CHANGE O2 CONCENTRATION SET TO 50 %. 2024-05-21 20:36:24 ALARM: O2 SUPPLY PRESSURE LOW. 2024-05-21 20:36:17 PARAMETER CHANGE O2 CONCENTRATION SET TO 100 %. 2024-05-21 20:35:34 ALARM: O2 SUPPLY PRESSURE LOW. 2024-05-21 20:35:23 PARAMETER CHANGE O2 CONCENTRATION SET TO 50 %. 2024-05-21 20:31:25 PARAMETER CHANGE FLOW SET TO 50 L/MIN. THE TECHNICAL LOG DOES NOT CONTAIN ANY TECHNICAL ERROR CODES TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION. THE VENTILATOR PASSED PRE-USE CHECK PRIOR AND AFTER THE EVENT DATE. OUR CONCLUSION IS THAT THERE WAS NO VENTILATOR MALFUNCTION. THE VENTILATOR DETECTED AND GENERATED ALARMS FOR O2 SUPPLY PRESSURE LOW MOST LIKELY DUE TO THAT THE GAS SUPPLY COULD NOT DELIVERY THE HIGH FLOW THAT THE VENTILATOR WAS SET TO. THE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF.#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR O2 SUPPLY PRESSURE LOW. PATIENT DESATURATED TO UNKNOWN LEVEL. FINAL PATIENT OUTCOME IS NO INJURY. MANUFACTURER'S REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780214 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Life Threatening