BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 4131788 · Received October 1, 2014

    Report

    Report Number
    2023050-2014-00409
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 9, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    NOU
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IS ON QUARENTINE AT THE CUSTOMER'S SITE. ALTHOUGH, IT IS EXPECTED TO BE RETURNED FOR A THOROUGH INVESTIGATION, IT HAS NOT YET BEEN RECEIVED.(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 GENERATED A "CHECK CIRCUIT" AND "LOW PRESSURE" ERROR CODE ALARMS. THE (B)(6) MALE PATIENT WAS DISCONNECTED FROM THE HT70 PLUS VENTILATOR FOR APPROXIMATELY 28 MINUTES, AND WAS TRANSFERRED TO ANOTHER VENTILATOR. AS A RESULT, THE PATIENT DEVELOPED AN ANOXIC BRAIN INJURY. ONE DAY LATER, HE WENT INTO CARDIAC ARREST, AND EXPIRED. PER CUSTOMER REPRESENTATIVE, IT WAS REPORTED THAT WHEN THE BIOMEDICAL TECHNICIAN CHECKED THE LOGS, IT WAS NOTICED THAT THE TIME AND DATE STAMP HAD RESET DUE TO LOW VOLT, AND REPORTEDLY, THE COIN CELL BATTERY WAS DEPLETED. AN O2 MIXER WAS ATTACHED TO THE UNIT DURING OPERATION. ADDITIONALLY, THE CUSTOMER REPRESENTATIVE INFORMED THAT HE BELIEVES THE VENTILATOR ALARMED PROPERLY. THE FACILITY HAS NOT PROVIDED THE SERIAL NUMBER OR ANY OTHER INFORMATION, AND THE VENTILATOR WAS IN QUARANTINE. IT WAS REQUESTED FOR THE O2 MIXER TO BE RETURNED FOR AN INVESTIGATION. THERE WAS NO ALLEGED MALFUNCTION ON THE UNIT. HOWEVER, THE UNIT IS EXPECTED TO BE RETURNED FOR A THOROUGH INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612245 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR NOU NEWPORT MEDICAL INSTRUMENTS, INC. HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R