BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION 3E

    MDR report key: 16250710 · Received January 26, 2023

    Report

    Report Number
    3006135941-2023-00003
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    December 27, 2022
    Report Date
    January 26, 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 (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM INTERFACE 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 EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM/SENSOR OFFSETS ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM INTERFACE 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
    1175423 EVOLUTION 3E VENTILATOR SYSTEM CBK EVENT MEDICAL LTD. EVOLUTION 3E T 00860008873606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention