BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 3181453 · Received June 14, 2013

    Report

    Report Number
    2023050-2013-00435
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 14, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, PATIENT USE, THE VENTILATOR SHUTDOWN WHEN IT WAS DISCONNECTED AND RECONNECTED FROM AN EXTERNAL POWER SOURCE. THE PATIENT WAS REMOVED FROM THE VENTILATOR. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272065 HT50 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention