BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 4101596 · Received August 25, 2014

    Report

    Report Number
    2023050-2014-00363
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 12, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR SENT A TECHNICIAN TO EVALUATE THE DEVICE. HOWEVER, THE REPORTED CONDITION COULD NOT BE DUPLICATED. THERE IS NO ADD'L INFO REGARDING THE CURRENT STATUS OF THIS UNIT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED FOR THE REPORTED "BACK-UP BATTERY" FAILURE. THE BATTERY PACK WAS PLACED INTO AN HT70 TEST VENTILATOR. THERE WAS NO FAULT FOUND. THE VENTILATOR OPERATED AS IT WAS INTENDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PATIENT USE, THE HT70 VENTILATOR GENERATED A BACK-UP BATTERY FAILURE ALARM. THE PATIENT'S MOTHER NOTICED THE ALARM, AND CONTINUED TO MONITOR THE CONDITION FOR A WHILE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513949 HT70 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention