BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 6137321 · Received November 30, 2016

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    Report

    Report Number
    2023050-2016-00716
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    November 1, 2016
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REF NUMBER: (B)(4). ALTHOUGH REQUESTED, THE SERIAL NUMBER OF THE VENTILATOR WAS NOT PROVIDED THEREFORE THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE E360 VENTILATOR HAD FAULTY OXYGEN (O2) SENSOR. ALTHOUGH REQUESTED, THE FOLLOWING INFORMATION WAS NOT PROVIDED: IF A PATIENT WAS IMPACTED BY THE REPORTED EVENT, PATIENT OUTCOME, AS WELL AS IF ANY INTERVENTION WAS REQUIRED ON BEHALF OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787829 E360 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC E360

    Patients

    Seq Age Sex Outcome Treatment
    1