BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREVENT DELUXE TRANSPORT VENTILATION CIRCUIT WITH PEEP PORT

    MDR report key: 379078 · Received February 27, 2002

    Report

    Report Number
    MW1024179
    Event Type
    Injury
    Date Received
    February 27, 2002
    Date of Event
    January 1, 2002
    Report Date
    February 27, 2002
    Manufacturer
    O-TWO SYSTEMS INTL, INC
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS PICKED UP BY AMBULANCE STAFF FROM HOSPITAL TO BE TRANSPORTED TO ANOTHER FACILITY FOR HYPERBARIC TREATMENT AND PT WAS CONNECTED TO THE VENTILATOR DURING TRANSPORT AT 12 BREATHS PER MINUTE. AMBULANCE STAFF NOTICED THAT PT'S O2 SATURATION DROPPED FROM 99% TO 68% AND SO THEY THOUGHT THEY HAD A VENTILATOR FAILURE. THEY STARTED BAGGING THE PT. ONE OF THE STAFF THEN NOTICED THAT THE TUBING TO THE VENTILATOR WAS ON BACKWARDS, CAUSING THE PT TO BE DEPRIVED OF OXYGEN. THE PT WAS THEN BAGGED WITH HIGH FLOW O2 AND THE PT'S O2 SATURATION RETURNED TO NORMAL. THE PROBLEM THAT THE AMBULANCE STAFF NOTICED WITH THE TUBING WAS DETERMINED TO BE A MANUFACTURING DEFECT, SINCE THE DEVICE CAME FROM THE FACTORY IN THAT WAY. THE DEFECTIVE TUBING WAS REPLACED BY THE AMBULANCE STAFF AND THE PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREVENT DELUXE TRANSPORT VENTILATION CIRCUIT WITH PEEP PORT VENTILATOR TUBING/CIRCUIT BZO O-TWO SYSTEMS INTL, INC 01CV8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention VENTILATOR