BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3112016 · Received May 7, 2013

    Report

    Report Number
    2023050-2013-00375
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 22, 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

    THOUGH REQUESTED, ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, A 'BACKUP BATTERY FAILURE' ALARM OCCURRED. THE UNIT WAS RE-CONNECTED TO THE AC POWER SUPPLY AND THE ISSUE WAS RESOLVED. THE PATIENT WAS MANUALLY VENTILATED AND THEN SWITCHED TO ANOTHER UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199910 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1