BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4101592 · Received August 25, 2014

    Report

    Report Number
    2023050-2014-00370
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 12, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    NOU
    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

    ALTHOUGH REQUESTED, THERE IS NO AVAILABLE INFO REGARDING THE EVALUATION AND REPAIR OF THIS DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PATIENT USE, THE HT70 PLUS VENTILATOR FILTER COVER GASKET DETACHED FROM THE UNIT. ALTHOUGH THE VENTILATOR CONTINUED CYCLING, THE PATIENT WAS TRANSFERRED TO ANOTHER UNIT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513912 HT70 VENTILATOR CONTINUOUS VENTILATOR NOU NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention