BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 1781005 · Received July 29, 2010

    Report

    Report Number
    3003135857-2010-00010
    Event Type
    Other
    Date Received
    July 29, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 30, 2010
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K992133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REPORTEDLY THE PT'S O2 SATURATION DECREASED WHILE BEING VENTILATED DURING A HOSPITAL TRANSFER TO ANOTHER HOSPITAL. NO PERMANENT PT INJURY WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL PT DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50 VENTILATOR CBK, NOU CBK FLIGHT MEDICAL HT50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention