BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 6071295 · Received November 1, 2016

    Report

    Report Number
    2023050-2016-00660
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    December 20, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER EVALUATED THE DEVICE AND VERIFIED THE REPORTED COMPLAINT. WHEN THE DEVICE WAS POWERED ON UNDER BATTERY POWER; THE DISPLAY OPERATES THROUGH THE POWER ON SELF-TEST BUT DID NOT PASS THE "PLEASE WAIT" SCREEN. THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PBC) WAS SWAPPED WITH A KNOWN GOOD SBC AND THE DEVICE OPERATED PROPERLY AND IT PASSED THE "PLEASE WAIT" SCREEN. THERE WERE NO VISIBLE ISSUES SEEN ON THE SBC. THE SBC AND RIBBON CABLE WILL BE REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE IN INITIAL REPORT SHOULD HAVE BEEN (B)(6) 2016. ADDITIONAL INFORMATION: THE VENTILATOR UNIT WAS A DEMO UNIT. THE SOLENOID VALVE AND THE SBC (SINGLE BOARD COMPUTER) WERE REPLACED BY THE SERVICE TECHNICIAN AND THE UNIT WAS RETURNED TO STOCK. AFTER REPAIRS WERE COMPLETED. IT WAS NOT RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO INTERFACE BETWEEN THE DEVICE AND THE FAILED COMPONENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING SERVICE, THE VENTILATOR DISPLAY FROZE AT THE PLEASE WAIT SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722598 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70

    Patients

    Seq Age Sex Outcome Treatment
    1