BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUDSON VENTILATOR MONITORING ADAPTOR CIRCUIT

    MDR report key: 1936088 · Received December 13, 2010

    Report

    Report Number
    3004365956-2010-00356
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 24, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN IF SAMPLE IS AVAILABLE FOR INVESTIGATION. THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: PATIENT WAS CONNECTED TO A HUDSON RCI CATALOG #1667, VENTILATOR MONITORING ADAPTOR CIRCUIT, LOT # UNKNOWN INSTEAD OF A HUDSON TRACHE "T" OXYGENATOR, CATALOG # 1668. IN THIS INSTANCE, THE ALLEGED MISAPPLICATION OF THE DEVICE RESULTED IN A FEMALE PATIENT SUFFERING PERMANENT BRAIN DAMAGE AND IS COMATOSE WHILE UNDERGOING AN UNDEFINED BIOPSY. THE HUDSON #1667 THAT WAS CONNECTED TO THE PATIENT ALLOWED GAS INHALATION, BUT PATIENT EXHALATION COULD NOT OVERCOME THE RESISTANCE OF THE ONE WAY GAS VALVES. DETAILED INFORMATION IS EXTREMELY LIMITED AT THIS TIME. ATTEMPTS ARE BEING MADE TO GET MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON VENTILATOR MONITORING ADAPTOR CIRCUIT ADAPTOR CIRCUIT BZO TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S