BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3193234 · Received June 25, 2013

    Report

    Report Number
    2023050-2013-00448
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 9, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, THE TOUCH PANEL DID NOT WORK. THE COIN BATTERY VOLTAGE WAS LOWER THAN THE SPECIFICATIONS. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287289 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1