BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 5693560 · Received June 1, 2016

    Report

    Report Number
    2023050-2016-00296
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Report Date
    May 5, 2016
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SINGLE BOARD COMPUTER PRINTED CIRCUIT BOARD WAS REPLACED AND THE DEVICE PASSED ALL TESTING.

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE NUMBER: (B)(4). THE VENTILATOR WAS RETURNED FOR EVALUATION. THE SERVICE ENGINEER EVALUATED THE DEVICE AND VERIFIED THE REPORTED COMPLAINT. WHEN THE DEVICE WAS TESTED THE TOUCH SCREEN WAS UNRESPONSIVE. THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED WITH A KNOWN WORKING TEST SBC PCB. THE DEVICE WAS POWERED ON AND OFF SEVERAL TIME AND THE DISPLAY REACTED TO TOUCH EACH TIME. THE ORIGINAL SBC PCB WAS VISUALLY INSPECTED FOR DAMAGE AND A MISSING DIODE WAS FOUND THAT IS KNOWN TO CAUSE AN UNRESPONSIVE TOUCHSCREEN. THE SBC PCB WILL BE REPLACED. THE REPORTED MALFUNCTION WAS DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTILATOR TOUCHSCREEN WAS INTERMITTENTLY UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347358 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70

    Patients

    Seq Age Sex Outcome Treatment
    1