BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4225534 · Received November 4, 2014

    Report

    Report Number
    2023050-2014-00461
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 7, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPLACED SINGLE BOARD CONTROL (SBC) PANEL WAS RECEIVED BY THE MANUFACTURER FOR FURTHER EVALUATION. THE SBC WAS EVALUATED AND WAS FOUND TO HAVE CONTRIBUTED TO THE REPORTED EVENT. UPON PLACING THE SBC IN A TEST VENTILATOR, THE DEVICE WAS FOUND TO FREEZE MULTIPLE TIMES DURING START-UP. THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AFTER THE REPLACEMENT OF THE AN HT70 VENTILATOR'S CIRCUIT THE DEVICE EXPERIENCED A FROZEN SCREEN UPON START-UP. THE DEVICE WAS REPORTED TO BE UNRESPONSIVE. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706037 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention