BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTECH

    MDR report key: 111821 · Received July 10, 1997

    Report

    Report Number
    111821
    Event Type
    Injury
    Date Received
    July 10, 1997
    Date of Event
    September 8, 1996
    Report Date
    April 11, 1997
    Manufacturer
    DELTECH ENGINEERING CENTURY PARK
    Product Code
    FRF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DRYER ON THE MEDICAL AIR SUPPLY SYSTEM FAILED TO REMOVE WATER AND THE LINE MONITOR FAILED TO ALARM. THE WATER IN THE SYSTEM CAUSED THE FLOW SENSOR ON THE VENTILATOR TO ALARM. HOWEVER THE VENTILATOR CONTINUED TO OPERATE. THE VENTILATOR WAS EXCHANGED WITHOUT PT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTECH MEDICAL AIR DRYER FRF DELTECH ENGINEERING CENTURY PARK 8M50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention NELTCOR, PURITAN BENNETT 7200 AE VENTILATOR| SN 9043077