BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 5093836 · Received September 22, 2015

    Report

    Report Number
    2023050-2015-00223
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    August 25, 2015
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) EVALUATED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED ISSUE. VISUAL INSPECTION OF VENTILATOR FOUND NO ANOMALIES. THE UNIT WAS POWERED UP AND PASSED THE POWER ON SELF-TEST (POST). THE DATA LOGS WERE REVIEWED AND SHOWED AND ERRATIC OXYGEN (02) READINGS. A LOW FLOW OXYGEN (02) RESERVOIR HAD BEEN CONNECTED TO THE UNIT. THE CSE REPLACED THE OXYGEN (O2) SENSOR. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND WAS FOUND TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING PATIENT USE, THE VENTILATOR DISPLAYED AN ALARM MESSAGE THAT THE FRACTION OF INSPIRED OXYGEN (FIO2) HAD FLUCTUATED FROM 0 TO 60 PERCENT. A LOW OXYGEN RESERVOIR WAS USED. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR WITHOUT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626099 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention