BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3954833 · Received July 17, 2014

    Report

    Report Number
    2023050-2014-00296
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 24, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE VENTILATOR REFERENCED IN THIS REPORT WAS NOT AVAILABLE DURING A FOLLOW-UP WITH THE USER FACILITY. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE OF THE HT70 VENTILATOR, WHEN THE NURSE TRIED TO REMOVE THE TUBE FROM THE AIR PRESSURE PORT, THE PORT BROKE FROM THE ROOT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420190 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention