BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 5213884 · Received November 10, 2015

    Report

    Report Number
    2023050-2015-00316
    Event Type
    Malfunction
    Date Received
    November 10, 2015
    Report Date
    November 28, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER (SE) EVALUATED THE VENTILATOR AND VERIFIED THE REPORTED MALFUNCTION. THE UNIT FAILED THE POWER ON SELF-TEST (POST), AND THE SYSTEM WOULD NOT LOAD THE PARAMETERS OR SETTINGS. THE SE TRIED TO RESET THE SYSTEM AND IT WOULD NOT POWER OFF OR RESET. A SOFTWARE RELOAD WAS UNSUCCESSFULLY ATTEMPTED. THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REMOVED AND REPLACED. THE VENTILATOR THEN PASSED ALL TESTS, CALIBRATIONS AND WAS FOUND TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PCB) WAS RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. THE RETURNED COMPONENT WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS; FUNCTIONALITY TEST WAS PERFORMED. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT THE REPORTED ISSUE WAS DUPLICATED; THE ROOT CAUSE WAS ISOLATED TO A COMPONENT (U700) ON THE PCB. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTILATOR DISPLAY BECAME STUCK ON THE START-UP SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743533 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1