BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1894103 · Received November 5, 2010

    Report

    Report Number
    2023050-2010-00052
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR ALARMED AND THEN SHUT DOWN. IT IS UNK HOW LONG THE ALARM SOUNDED BEFORE IT SHUT DOWN. THE PT WAS IMMEDIATELY SWITCHED TO ANOTHER VENTILATOR. PLEASE NOTE THAT THERE WAS NO INJURY TO THE PT IN THIS CASE. IF THIS WERE TO RECUR, AND THE CAREGIVER DID NOT RESPOND IN A TIMELY FASHION, THEN THE PT COULD BE HARMED BY A LACK OF VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT50-H1B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK