BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3834515 · Received March 18, 2014

    Report

    Report Number
    2023050-2014-00109
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 9, 2014
    Report Date
    February 28, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE DEVICE AND REPLACED THE BACK UP BATTERY. THE UNIT PASSED EXTENDED SELF-TESTING.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT THERE WAS A BACKUP BATTERY FAILURE. THE DEVICE WAS NOT IN USE ON A PT WHEN THIS EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159671 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70M

    Patients

    Seq Age Sex Outcome Treatment
    1