BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 3874054 · Received June 4, 2014

    Report

    Report Number
    2023050-2014-00229
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 14, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMEN
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Removal / Correction Number
    Z-1577-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE E360 VENTILATOR REPAIR IS NOT YET COMPLETED. (B)(4). CAPA IS AT "OPEN INVESTIGATION", AND THE INVESTIGATION IS AT "OPEN IMPLEMENTATION" WORKFLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT DURING PATIENT USE OF THE E360 VENTILATOR, THE AUDIBLE ALARM WAS NOT FUNCTIONING, ALTHOUGH, THE UNIT CONTINUED TO CYCLE. THE PATIENT WAS TRANSFERRED TO AN ALTERNATIVE VENTILATOR, AND THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326789 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMEN E360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention