BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 1081030 · Received July 18, 2008

    Report

    Report Number
    2023050-2008-00053
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 18, 2008
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - WHILE SERVICING THIS CUSTOMER OWNED VENTILATOR, IT WAS FOUND THAT THERE WAS NO AUDIBLE ALARM. FURTHER INVESTIGATION FOUND THAT THE AUDIBLE BOARD PCB2106P WAS DEFECTIVE. A NEW PCB2106P BOARD WAS REPLACED IN THE VENTILATOR, AND NO FURTHER ISSUES WERE FOUND.

    Description of Event or Problem · 1

    REPORTEDLY WHILE THIS CUSTOMER OWNED VENTILATOR WAS BEING SERVICED AT NEWPORT MEDICAL. IT WAS NOTED THAT THERE WAS NO AUDIBLE ALARM DUE TO A DEFECTIVE AUDIBLE BOARD. PLEASE NOTE, THERE WAS NO PT INVOLVEMENT FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA