BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4092782 · Received August 19, 2014

    Report

    Report Number
    2023050-2014-00377
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 15, 2014
    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

    THE CUSTOMER REPLACED THE CIRCUIT, BUT THE PROBLEM WAS NOT RESOLVED. THE TECHNICIAN EVALUATED AND TESTED THE CIRCUIT, BUT IT DID NOT PASS THE FIRST STEP. AT THE TIME, THE TECHNICIAN OBSERVED AN ABNORMAL NOISE, WHICH SEEMED LIKE A LEAK HAS OCCURRED INTERNALLY. THE REPAIR OF THIS VENTILATOR HAS NOT BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING A PATIENT USE, THE HT70 VENTILATOR GENERATED A "REPLACE CIRCUIT" ALARM. THE CIRCUIT WAS REPLACED, BUT DID NOT RESOLVE THE ISSUE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497007 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention