BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 2792093 · Received October 11, 2012

    Report

    Report Number
    2023050-2012-00209
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 23, 2012
    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

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, A 'BACKUP BATTERY FAILURE' ALARM OCCURRED ON AC POWER. THE VENTILATOR KEPT VENTILATING; HOWEVER, THE PT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. NO PERMANENT INJURY WAS REPORTED IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention