BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 6604436 · Received June 1, 2017

    Report

    Report Number
    2023050-2017-05367
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    March 10, 2017
    Report Date
    April 25, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A SINGLE BOARD COMPUTER (SBC) WAS RETURNED TO COVIDIEN/MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION FOUND NO NOTABLE CONDITIONS. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT THE IDENTIFIED ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO SOFTWARE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A TIME OF MAINTENANCE, THE HT70 VENTILATOR'S SCREEN FROZE AT THE 6 PHOTOS IMAGE. THERE WAS NO PATIENT INVOLVEMENT. THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AND THE PROBLEM WAS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A TIME OF MAINTENANCE, THE SCREEN FROZE AT THE 6 PHOTOS IMAGE. NO PATIENT INVOLVEMENT. THE SBC BOARD WAS REPLACED AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386964 HT70 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1