BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION 3E HP

    MDR report key: 15213767 · Received August 11, 2022

    Report

    Report Number
    3006135941-2022-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 9, 2022
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    UDI-DI
    B079EVL100500T1
    PMA / PMN Number
    K113743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    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 AIR SUPPLY ALARM . THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: 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 DAUFGHTER 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
    1942682 EVOLUTION 3E HP VENTILATOR SYSTEM CBK EVENT MEDICAL LTD. EVOLUTION 3E HP B079EVL100500T1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention