BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 6206089 · Received December 27, 2016

    Report

    Report Number
    2023050-2016-00793
    Event Type
    Injury
    Date Received
    December 27, 2016
    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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VENTILATOR UNIT WAS RETURNED FOR INVESTIGATION. THE REPORTED ISSUE COULD ONLY BE CONFIRMED IN THE EVENT LOGS. THE DEVICE WAS FOUND TO FUNCTION NORMALLY. THE UNIT WAS REPAIRED PER SERVICE INSTRUCTIONS AND WAS RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED AND THE TECHNICIAN FOUND THAT THE REPORTED PROBLEM COULD NOT BE DUPLICATED. NO FAILURE WAS DETECTED. 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 STARTED AUTO CYCLING AND ALARMED WHEN PLACED ON PATIENT. THE VENTILATOR STARTED TO DELIVER APPROXIMATELY 40 BREATHS PER MINUTE AND THE DISPLAY MESSAGE WAS GARBLED. AFTER TWO ATTEMPTS TO PLACE PATIENT ON UNIT, THE PATIENT WAS TRANSFERRED TO A DIFFERENT VENTILATOR. THERE WAS NO PATIENT HARM/INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857073 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention