BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 6281860 · Received January 26, 2017

    Report

    Report Number
    2023050-2017-00074
    Event Type
    Death
    Date Received
    January 26, 2017
    Report Date
    December 20, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED THE SINGLE BOARD COMPUTER (SBC) AND THE COIN BATTERY. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO AN ISSUE WITH THE POWER SOURCE FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAS A TIME/DATE, COIN BATTERY FAILURE AND THEY WERE UNABLE TO USE IT ON A PATIENT. CUSTOMER INFORMED THAT THE PATIENT WAS CODING UPON ARRIVAL AND WAS BAGGED BUT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61576 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death