BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 6055149 · Received October 25, 2016

    Report

    Report Number
    2023050-2016-00648
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 30, 2016
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE. A NON-MEDTRONIC TECHNICIAN CHECKED THE DEVICE BUT THE REPORTED CONDITION WAS NOT CONFIRMED, THE DEVICE WAS WORKING PROPERLY AND NO ANOMALY WAS FOUND ON THE SCREEN.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE THE VENTILATOR DISPLAY SCREEN TURNED WHITE. THE DEVICE CONTINUED VENTILATING/CYCLING. THE PATIENT WAS TRANSFERRED TO A DIFFERENT VENTILATOR. THERE WAS NO PATIENT HARM/INJURY REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ALTHOUGH MEDTRONIC/COVIDIEN WAS NOT AUTHORIZED TO CONDUCT REPAIRS, THE CUSTOMER RETURNED A SPEAKER CABLE ASSEMBLY, SINGLE BOARD COMPUTER (SBC) RESET CABLE, AUDIO BOARD, AND A PIN CABLE. AN INVESTIGATION WAS PERFORMED ON THE RETURNED COMPONENTS BUT THE ALLEGED CONDITION COULD NOT BE CONFIRMED. IT WAS FOUND; HOWEVER, THAT THE TRACE FROM ONE OF THE CONNECTORS OF THE AUDIO BOARD WAS BURNT AS WELL AS THE PLASTIC OF THE PIN CABLE WAS FOUND TO BE SLIGHTLY MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705662 E360 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC E360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention