BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4221157 · Received November 3, 2014

    Report

    Report Number
    2023050-2014-00454
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 7, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SINGLE BOARD COMPUTER (SBC), A CONTROL BOARD, AND A BATTERY CONNECTOR BOARD (PCB) WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION WAS PERFORMED AND NO ANOMALIES WERE FOUND. AN HT70 PLUS TEST VENTILATOR WAS USED FOR FUNCTIONALITY TESTS OF THE RETURNED COMPONENTS. THE TEST VENTILATOR WAS POWER CYCLED MULTIPLE TIMES AND IT STARTED VENTILATING ON EACH TIME. ADDITIONALLY, THE DEVICE WAS LEFT RUNNING FOR AN EXTENDED PERIOD OF TIME, AND NO ALARMS OR ALERTS WERE GENERATED. THE COMPONENTS WERE FOUND TO BE OPERATING WITHIN THE MANUFACTURING SPECIFICATIONS. THE CUSTOMER REPORTED MALFUNCTION WAS NOT VERIFIED.

    Additional Manufacturer Narrative · 1

    COVIDIEN HAS REQUESTED RETURN OF THE DEVICE. IT IS REPORTED THAT THERE WAS NO OXYGEN MIXER IN USE ON THE DEVICE.(B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE OF THE HT70 VENTILATOR, AN SPO2 ALARM WAS GENERATED. WHEN THE NURSE WENT TO CHECK, SHE FOUND THAT THE DEVICE WAS IN A STAND-BY MODE AND THE VENTILATION HAD STOPPED.THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702643 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention