BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 2902988 · Received December 21, 2012

    Report

    Report Number
    2023050-2012-00347
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 25, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, ADDITIONAL PT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING PT USE, AND "INTEGRATED POWER PAC LOW" ALARM OCCURRED WHEN THE AC CABLE WAS REMOVED IN ORDER TO SWITCH TO BATTERY OPERATION. HOWEVER, THE VENTILATOR DID NOT RECOGNIZE THE POWER PAC BATTERY. THE PT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. NO PERMANENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1