BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3851106 · Received May 22, 2014

    Report

    Report Number
    2023050-2014-00216
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 25, 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

    NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. AS INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) STATED AN HT70 VENTILATOR EXPERIENCED A BACKUP BATTERY FAILURE WHILE CONNECTED TO THE ALTERNATING CURRENT (A/C). THERE WAS A PT CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT. THE PT WAS REMOVED FROM THE DEVICE, MANUALLY VENTILATED THEN TRANSFERRED TO AN ALTERNATE VENTILATOR. THERE WAS NO REPORTED NEGATIVE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306560 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention