BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 2850106 · Received November 27, 2012

    Report

    Report Number
    2023050-2012-00299
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 31, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, ADD'L PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, THE SILENCE/RESET LED BLINKED ON AND OFF AND ALARM DID NOT FUNCTION CORRECTLY. THE PT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. NO PERMANENT INJURY WAS REPORTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention