BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 2241542 · Received August 9, 2011

    Report

    Report Number
    2023050-2011-00036
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DR FOUND THAT THE VENTILATOR DID NOT AUDIBLY ALARM WHILE THERE WAS A VISUAL ALARM WITH ERROR MESSAGE. THIS INCIDENT WAS FOUND DURING THE TESTING OF THE DEVICE. THE VENTILATOR CONTINUED TO VENTILATE NORMALLY EVEN THOUGH ALARM DID NOT SOUND. THERE WAS NO PT INVOLVEMENT IN THIS CASE. HOWEVER, IF IT WERE TO RECUR, A CAREGIVER WOULD NOT BE ALERTED IN THE CASE THAT THE VENTILATOR GOES WRONG.

    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