BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 1220835 · Received October 30, 2008

    Report

    Report Number
    2023050-2008-00076
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    August 9, 2008
    Report Date
    October 17, 2008
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EVAL FOUND THAT THE COMPACT FLASH WAS DEFECTIVE WITH A CORRUPTED GDM. EXE FILE. REPLACEMENT OF THE COMPACT FLASH CARD CORRECTED THIS ISSUE.

    Description of Event or Problem · 1

    REPORTEDLY, DURING USE ON A PT, THERE WAS AN ERROR MESSAGE: "CAN NOT OPEN BITMAP FILES. ALL.C/360". THE VENTILATOR CONTINUED TO VENTILATE WITHOUT ANY PROBLEMS. THE HOSPITAL STAFF TURNED OFF THE VENTILATOR AND TURNED BACK ON AGAIN TO TRY TO CORRECT IT. PLEASE NOTE THAT THERE WAS NO PT INJURY OR MEDICAL INTERVENTION OCCURRED IN THIS CASE. INVESTIGATION OF THIS ISSUE HAS FOUND THAT WHEN THIS ERROR MESSAGE OCCURS THE PT CONTINUES TO BE VENTILATED, HOWEVER, IF A SUBSEQUENT ALARM EVENT WERE TO OCCUR, THERE WOULD BE A VISUAL ALARM, BUT NO AUDIBLE ALARM WOULD SOUND TO ALERT THE CAREGIVER OR HOSPITAL STAFF. THIS SPECIFIC ERROR MESSAGE HAS ONLY BEEN NOTED IN THE FOREIGN LANGUAGE 3.1B VERSION OF THE VENTILATOR SOFTWARE.

    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 UNK