BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT70 VENTILATOR

    MDR report key: 3065648 · Received April 15, 2013

    Report

    Report Number
    2023050-2013-00311
    Event Type
    Death
    Date Received
    April 15, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 22, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, WHILE ON THE VENTILATOR, A PATIENT DIED; CAUSED BY DISCONNECTING THE BREATHING CIRCUIT. IT IS UNKNOWN IF THERE WAS A MALFUNCTION OF THE DEVICE. THE VENTILATOR IN QUESTION IS NOT AVAILABLE FOR INVESTIGATION AT THIS TIME. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160374 HT70 VENTILATOR NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Death