BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIOX VENTILATOR HOSE

    MDR report key: 9676889 · Received February 5, 2020

    Report

    Report Number
    MW5092799
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    February 1, 2020
    Report Date
    February 3, 2020
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE MONITORING OF HELIOX CYLINDER PRESSURE GAUGE, PRESSURE READ 250 PSI. THE RESPIRATORY THERAPIST BEGAN THE PROCESS OF REPLACING THE TANK WITH A FULL ONE. AFTER SECURELY THE REGULATOR TO THE FULL TANK, THE TANKS VALVE WAS TURNED ON AND A LOUD POP WAS HEARD, A RUPTURE WAS FOUND IN THE SUPPLY LINE. AFTER THE HOSE RUPTURED, A SHORTER REPLACEMENT HOSE WAS USED TO CONTINUE THE THERAPY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133023 HELIOX VENTILATOR HOSE VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. TTNO 559569

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention