BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 6487781 · Received April 12, 2017

    Report

    Report Number
    2023050-2017-05151
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    September 4, 2015
    Report Date
    September 29, 2015
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    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 PRIOR TO PLACING A PATIENT ON THE HT70 VENTILATOR, IT WOULD NOT START UP BY PRESSING THE SWITCH. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT. INFORMATION REGARDING IF THE THERE WAS A DELAY IN THE PATIENTS THERAPY AND IF THE PATIENT WAS MANUALLY VENTILATED / AMBU BAGGED WAS REQUESTED HOWEVER COULD NOT BE OBTAINED FROM THE CUSTOMER. THE CUSTOMER COULD NOT DUPLICATE THE REPORTED ISSUE REFERENCE REGULATORY REPORT #2023050-2017-05139 PREVIOUSLY REPORTED FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270170 HT70 PLUS VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention