BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAX TRANSPORT

    MDR report key: 10763 · Received January 4, 1994

    Report

    Report Number
    10763
    Event Type
    Death
    Date Received
    January 4, 1994
    Date of Event
    October 16, 1993
    Report Date
    November 15, 1993
    Manufacturer
    HAMILTON MEDICAL
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR DEPENDENT PT IN CT SCAN DEVELOPED RESPIRATORY DISTRESS. INVESTIGATION REVEALED THAT THE EXTERNAL VENTILATOR CIRCUIT WAS PROBABLY ASSEMBLED INCORRECTLY. THE VENTILATOR CIRCUIT FOR THIS UNIT USED AN IPPB EXHALATION VALVE. A DART UNIVERSAL EXHALATION VALVE WAS PROBABLY USED VERSUS THE DART IPPB EXHALATION VALVE. IF THE INCORRECT EXHALATION VALVE WAS USED, IT MAY HAVE NOT ALLOWED THE PT THE OPPROTUNITY TO EXHALE. THE PT CIRCUIT WAS DISCARDED AND WAS NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAX TRANSPORT VENTILATOR CBK HAMILTON MEDICAL MAX TRANSPORT

    Patients

    Seq Age Sex Outcome Treatment
    1 88 * Death DART PT CIRCUIT