BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION 3E

    MDR report key: 17312676 · Received July 12, 2023

    Report

    Report Number
    3006135941-2023-00015
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 12, 2023
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    UDI-DI
    00860008873606
    PMA / PMN Number
    K113743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190935 EVOLUTION 3E VENTILATOR SYSTEM CBK EVENT MEDICAL LTD. EVOLUTION 3E T 00860008873606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention