BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1918301 · Received December 2, 2010

    Report

    Report Number
    2023050-2010-00054
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 8, 2010
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED VENTILATOR DID NOT CONFIRM THAT THE VENTILATOR STOPPED VENTILATION. DURING THE TESTING, THE VENTILATOR SHOWED WHITE SCREEN AS REPORTED; HOWEVER, THE FROZEN MONITOR WITH PRE-SET FIGURES COULD NOT BE DUPLICATED. ALSO, THE VENTILATOR DID NOT STOP VENTILATING AT ANY TIME; IT CONTINUED TO DELIVER BREATH TO THE PT CIRCUIT NORMALLY AND ACCEPTED ALL NEW PARAMETER SETTINGS ON THE MEMBRANE SWITCHES. THE ISSUE WITH WHITE SCREEN AND "NO COMMUNICATION" WAS CAUSED BY THE FAULTY COMPONENT ON THE SINGLE BOARD COMPUTER.

    Description of Event or Problem · 1

    REPORTEDLY, DURING USE ON A VENTILATOR DEPENDENT PT, THE VENTILATOR'S GRAPHIC MONITOR BECAME WHITE SCREEN AND THE SETTING MONITOR WAS FROZEN WITH PRE-SET FIGURES. THE ICU NURSE NOTICED THE AUDIBLE ALARM ALONG WITH LED RED LAMP. THE NURSE ALSO NOTICED THAT THE PT NO LONGER APPEARED TO BE BREATHING AND THAT LED HER TO THINK THE VENTILATOR HAD STOPPED VENTILATING. HOWEVER, SHE DID NOT CHECK THE VENTILATOR TO CONFIRM IF THE VENTILATOR TRULY HAD STOPPED VENTILATION. THE PT WAS AMBU BAGGED AND THEN SWITCHED TO ANOTHER VENTILATOR. THERE WAS NO PT INJURY IN THIS CASE. THE VENTILATOR WAS IMMEDIATELY TAKEN TO ANOTHER ROOM FOR A MEDICAL ENGINEER TO DUPLICATE THE PROBLEM. HOWEVER, THE PHENOMENON (THE UNIT STOPPED VENTILATION) WAS UNABLE TO BE DUPLICATED. IN THE EVENT HISTORY LOG, "NO COMMUNICATION" WAS RECORDED AND THERE WAS NO "DEVICE ALERT" IN THE LOG.

    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 63 YR Required Intervention