BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3352698 · Received August 30, 2013

    Report

    Report Number
    2023050-2013-00587
    Event Type
    Death
    Date Received
    August 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    August 1, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED MEDWATCH FORM ALLEGING DEFICIENCY OF ALARM. TO DATE, NO EVIDENCE OF MALFUNCTION THAT CONTRIBUTED TO PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429499 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death