BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 4109179 · Received September 8, 2014

    Report

    Report Number
    2023050-2014-00385
    Event Type
    Death
    Date Received
    September 8, 2014
    Date of Event
    August 17, 2014
    Report Date
    September 4, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    NOU
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS EVALUATED BY THE FACILITY RESPIRATORY THERAPIST MANAGER. HE STATED THAT THE VENTILATOR FUNCTIONED AS INTENDED INCLUDING LOW PRESSURE ALARMS BASED ON A PERFORMANCE CHECK AND LOG REVIEW. THE CIRCUIT WAS NOT A COVIDIEN PRODUCT. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT A PATIENT ON A HT70 PLUS VENTILATOR WAS ON AN OUTING AWAY FROM THE REPORTING REHABILITATION FACILITY WITH A FAMILY MEMBER. DURING THE OUTING,THE CIRCUIT WAS REPORTED TO BE "BROKEN" OR DISCONNECTED CREATING A LEAK AND THE VENTILATOR AUDIBLY AND VISUALLY ALARMED LOW PRESSURE. THE FAMILY MEMBER THEN MADE THE DECISION TO TRANSPORT THE PATIENT BACK TO THE FACILITY WITH THE VENTILATOR ON THE PATIENT RATHER THAN CALL 911 AN MANUALLY VENTILATE THE PATIENT WHILE WAITING FOR THE FIRST RESPONDERS. WHEN THE PATIENT ARRIVED BACK AT THE FACILITY THE CIRCUIT WAS REPLACED. SUBSEQUENTLY, THE PATIENT HAD A CARDIAC ARREST AND RESUSCITATION WAS INITIATED. THE PATIENT WAS TRANSPORTED TO AN ACUTE CARE FACILITY AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551210 HT70 PLUS VENTILATOR CONTINOUS VENTILATOR NOU NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death