BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50-H1 VENTILATOR

    MDR report key: 3001392 · Received March 11, 2013

    Report

    Report Number
    2023050-2013-00164
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 28, 2013
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE VENTILATOR WAS RETURNED TO NEWPORT MEDICAL INSTRUMENTS INC FOR NECESSITATION. THE UNIT WAS ALLOWED TO VENTILATE AND THE TIDAL VOLUMES DELIVERED WERE MEASURED AND CONFIRMED THAT THE VOLUMES WERE WITHIN TOLERANCE AT THE OUTPUT PORT OF THE VENTILATOR. THE VENTILATOR WAS DELIVERING THE APPROPRIATE TIDAL VOLUMES. HOWEVER, THE VOLUMES DELIVERED TO THE PT SIDE WERE MEASURED LOW CONFIRMING THE REPORTED ISSUE. THE ISSUE WAS DUE A LEAK ON THE EXHALATION VALVE DURING THE INSPIRATORY PHASE WHICH WAS CAUSED BY LEAK ON THE SOLENOID ASSEMBLY LEAKING ON THE MANIFOLD. REPLACING THE SOLENOID ASSEMBLY RESOLVED THE EXHALATION VALVE GAS LEAKAGE AND LOW VOLUMES. NOTE: THE VENTILATOR WAS DUE FOR THE ANNUAL PREVENTIVE MAINTENANCE. THE VENTILATOR WILL BE REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSPITAL WITH HYPERCAPNIA AND HYPOXEMIA. REPORTEDLY, THE VENTILATOR WAS DELIVERING LOW TIDAL VOLUMES TO THE PT. THE VENTILATOR WAS EXCHANGED FOR A DIFFERENT UNIT. NO PERMANENT PT INJURIES WERE REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102134 HT50-H1 VENTILATOR CBK, NOU CBK FLIGHT MEDICAL HT50-H1

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention