BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 2092894 · Received May 4, 2011

    Report

    Report Number
    2023050-2011-00015
    Event Type
    Other
    Date Received
    May 4, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: DEVICE EVAL ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE HEARD A LOUD VIBRATING NOISE FROM THE VENTILATOR WHILE ATTENDING THE PT. THE PT WAS MANUALLY VENTILATED UNTIL SHE WAS TRANSFER TO A SECOND VENTILATOR. NO SERIOUS PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50 VENTILATOR CBK NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT50-H1B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention