BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 6165000 · Received December 11, 2016

    Report

    Report Number
    2023050-2016-00732
    Event Type
    Injury
    Date Received
    December 11, 2016
    Date of Event
    October 2, 2016
    Report Date
    December 20, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SERIAL NUMBER OF THE VENTILATOR WAS NOT PROVIDED THEREFORE THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED A MIXER. AN INVESTIGATION WAS PERFORMED ON THE RETURNED COMPONENT; HOWEVER, THE ALLEGED MALFUNCTION COULD NOT BE CONFIRMED.THE CUSTOMER HAD REPLACED THE MIXER AND THE VENTILATOR WAS RETURNED TO USE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED AND THE TECHNICIAN FOUND THAT THE REPORTED PROBLEM COULD NOT BE DUPLICATED. NO FAILURE WAS DETECTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR'S MIXER GENERATED AN ABNORMAL NOISE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815688 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention