BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 6486902 · Received April 12, 2017

    Report

    Report Number
    2023050-2017-05150
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    December 2, 2014
    Report Date
    December 4, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE HT50 VENTILATOR INSPIRATION: EXPIRATION (I:E) VALUE BECAME 1:1.0. A TECHNICIAN PRESSED THE I:E BUTTON THEN THE VALUE BECAME 1:3.0. THE VENTILATOR DID NOT STOP CYCLING. HOWEVER, THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED ISSUE. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE. REFERENCE REGULATORY REPORT #2023050-2017-05138 PREVIOUSLY REPORTED FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268094 HT50 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention