BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 4879807 · Received June 30, 2015

    Report

    Report Number
    2023050-2015-00138
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 11, 2015
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE VENTILATOR WAS RETURNED FOR EVALUATION. IT WAS POWERED ON AND PASSED THE POWER ON SELF-TEST (POST). THE EVENT LOG WAS CHECKED AND A COMMUNICATION ERROR MESSAGE WAS FOUND. THE UNIT WAS RUN OVERNIGHT AND NO ERRORS WERE FOUND. THE TOP COVER WAS REMOVED AND FOUND THAT THE CONNECTOR HOLDING THE CABLE ASSEMBLY TO THE SINGLE BOARD COMPUTER (SBC) WAS LOOSE. THE CONNECTOR WAS RESEATED AND THE UNIT WAS ALLOWED TO RUN FOR SEVERAL DAYS. THE SBC AND THE CABLE ASSEMBLY WERE REMOVED FROM THE UNIT AND A VISUAL INSPECTION WAS PERFORMED. NO ANOMALIES WERE OBSERVED. HOWEVER BOTH WERE REPLACED AS A PRECAUTION. THE CUSTOMER REPORTED COMPLAINT WAS VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, A VENTILATOR SCREEN FROZE, DISPLAYED A ¿NO COMMUNICATION¿ ALERT MESSAGE, AND MADE A SOFT HIGH PITCHED ALARM. THE DEVICE CONTINUED TO VENTILATE AND THE PATIENT WAS ABLE TO BREATHE SPONTANEOUSLY. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER VENTILATOR WITHOUT HARM. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422164 E360 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention