BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 3851108 · Received May 22, 2014

    Report

    Report Number
    2023050-2014-00212
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 27, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING THAT AN E360 VENTILATOR EXPERIENCED A MALFUNCTION DURING PATIENT USE. THE CUSTOMER REPORTED THAT THERE WAS A LEAKING SOUND COMING FORM INSIDE THE E360 VENTILATOR. UPON INSPECTION, IT WAS FOUND THAT THE CONNECTOR BETWEEN THE SERVO VALVE AND THE ANALOG PRINTED CIRCUIT BOARD (PCB) AT THE AIR SIDE WAS LOOSE. THE PATIENT WAS MANUALLY VENTILATOR. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306659 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention