BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3935725 · Received June 23, 2014

    Report

    Report Number
    2023050-2014-00253
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 27, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO REPORT ABOUT THE UNIT BEING EVALUATED OR REPAIRED YET. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE VENTILATOR EXPERIENCED A LOSS OF VENTILATION. THE CUSTOMER RETURNED THE PRINTED CIRCUIT BOARD (PCB) FOR INVESTIGATION. THE PCB WAS INSTALLED IN A TEST VENTILATOR. THE UNIT WAS POWERED UP AND PAST TESTING. THE UNIT WAS THEN RUN FOR SEVEN DAYS. NO ERRORS OR ALARMS WERE LOGGED. THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PATIENT USE, AN HT70 VENTILATOR WENT INTO STANDBY MODE AFTER START UP, AND SHUT DOWN AFTERWARDS. THE UNIT REBOOTED BY ITSELF, AND THE SETTINGS REVERTED TO THE MANUFACTURER SETTINGS. THE SETTINGS WERE CHANGED, AND THE VENTILATOR PROPERLY FUNCTIONED. WHEN THE SERVICE STAFF ARRIVED, THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364879 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention