BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3954633 · Received July 11, 2014

    Report

    Report Number
    2023050-2014-00290
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 20, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN RECEIVED THE VENTILATOR FOR INVESTIGATION AND REPAIR. THE FAILURE INVESTIGATION ENGINEER WAS UNABLE TO DUPLICATE THE CUSTOMER'S REPORTED MALFUNCTION. ON THE DATA RESET, IT WAS REVERTED TO (B)(6) 2006. THE COIN BATTERY WAS REPLACED, AND THE SOFTWARE WAS UPGRADED TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MFG SPECS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PT USE, THE HT70 VENTILATOR EXHIBITED AN ERROR CODE "SYSTEM ERROR", AND THE DEVICE ALERT LIGHT WAS LIT. THE UNIT COULD NOT BE TURNED OFF. DURING THIS TIME, THE ALARMS COULD NOT BE SILENCED, AND THE SCREENS COULD NOT BE CHANGED. AFTER REBOOTING THE VENTILATOR, A REVIEW OF THE EVENT LOG SHOWED A DATE OF (B)(6) 2006. THE PT WAS SWITCHED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407944 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention