BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 4101586 · Received August 25, 2014

    Report

    Report Number
    2023050-2014-00373
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 31, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND VERIFIED THAT THE PLASTIC FRAME HOLDING THE FLOW SENSOR CONNECTOR AGAINST THE FRONT PLATE HAD BECOME UNGLUED. THE FRAME AND CONNECTOR WAS RE-GLUED TO FRONT PLATE. THE FLOW SENSOR WAS FOUND TO BE FUNCTIONING WITHOUT ISSUES. THE CSE TESTED AND REPLACED THE BATTERY, AND IT RESOLVED THE ISSUE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, THE HT70 PLUS VENTILATOR FAILED TO RECOGNIZE THE EXTERNAL FLOW SENSOR. IT WAS REPLACED, BUT THE ISSUE REMAINED. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513900 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention