BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 6609934 · Received June 2, 2017

    Report

    Report Number
    2023050-2017-05385
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    April 17, 2017
    Report Date
    May 17, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN HT70 VENTILATOR WAS RETURNED TO COVIDIEN/MEDTRONIC¿S FAILURE ANALYSIS. NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. AN INVESTIGATION WAS PERFORMED AND THE FAILURE ANALYSIS TECHNICIAN REPORTED THAT THE REPORTED CONDITION COULD NOT BE DUPLICATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AN HT70 VENTILATOR WAS RETURNED TO COVIDIEN/MEDTRONIC¿S FAILURE ANALYSIS. NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. AN INVESTIGATION WAS PERFORMED AND THE FAILURE ANALYSIS TECHNICIAN REPORTED THAT THE REPORTED CONDITION COULD NOT BE DUPLICATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING PATIENT USE, THE HT70 VENTILATOR WAS NOT FUNCTIONING PROPERLY. THE PATIENT¿S ARTERIAL BLOOD GAS (ABG) WAS ABNORMAL. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389726 HT70 PLUS VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS INC. HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention