BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3913240 · Received June 11, 2014

    Report

    Report Number
    2023050-2014-00242
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 15, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HT70 VENTILATOR WAS NOT REPAIRED YET, AND THE INVESTIGATION IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PT USE, THE HT70 VENTILATOR LIGHT EMITTING DIODE (LED) FOR THE ALARM SILENCE/RESET BUTTON WAS BLINKING INTERMITTENTLY. THE PT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343853 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention