BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 2932307 · Received January 24, 2013

    Report

    Report Number
    2023050-2013-00055
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 9, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT
    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, ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING PATIENT USE, A "SWITCHED TO BACKUP BATTERY" OCCURRED WHEN THE AC CABLE WAS REMOVED. THE POWER PAC BATTERY WAS REPLACED. HOWEVER, THE ISSUE WAS NOT RESOLVED. THE BATTERY WAS REPLACED AGAIN WITH A NEW ONE WHICH RESOLVED THE ISSUE. THE PATIENT WAS AMBU BAGGED AND TRANSFERRED TO ANOTHER VENTILATOR. NO PERMANENT PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34787 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENT HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention