BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3964636 · Received May 30, 2014

    Report

    Report Number
    2023050-2014-00225
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE USA RETURNED THE HT70 VENTILATOR ALARM SILENCE RESET MEMBRANE AND OVERLAY FOR REPLACEMENT. THE PART WAS RECEIVED AND DECONTAMINATED. HOWEVER, NO EVALUATION WAS PERFORMED YET. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT THE HT70 VENTILATOR ALARM SILENCE/RESET BUTTON WAS INOPERATIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320002 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1