BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E500 VENTILATOR

    MDR report key: 3040533 · Received April 3, 2013

    Report

    Report Number
    2023050-2013-00266
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    December 14, 2012
    Report Date
    March 14, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, AN O2 SENSOR ERROR OCCURRED. CALIBRATION OF THE OXYGEN SENSOR DID NOT RESOLVE THIS ISSUE. UPON REPLACING THE SENSOR, THE UNIT WORKED NORMALLY. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136088 E500 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENT E500

    Patients

    Seq Age Sex Outcome Treatment
    1