BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS 750 DUAL CUFF CONTROL VALVE

    MDR report key: 683799 · Received March 8, 2006

    Report

    Report Number
    9681444-2006-00001
    Event Type
    Injury
    Date Received
    March 8, 2006
    Date of Event
    November 17, 2005
    Report Date
    March 3, 2006
    Manufacturer
    DELFI MEDICAL INNOVATIONS, INC.
    Product Code
    KCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "WHILE USING THE DUAL CONTROL VALVE WITH HOSES THAT ATTACH TO THE UNIT, ONE SIDE OF THE VALVE DID NOT FUNCTION FOR INFLATION OR DEFLATION ON THE PATIENT. SURGERY MANAGER SAID IT WAS THE RESULT OF THE HOSE WITH THE VALVE AND NOT THE MACHINE MALFUNCTION. AS A RESULT, PATIENT RECEIVED A LARGE BOLUS OF LIDOCAINE AND WENT INTO AN ARRHYTHMIA. ANESTHESIOLOGY STABILIZED PATIENT. INSTALL DTE FOR TOURNIQUET 11/2002. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS 750 DUAL CUFF CONTROL VALVE CONTROL VALVE FOR PNEUMATIC TOURNIQUET KCY DELFI MEDICAL INNOVATIONS, INC. 9-0750-001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention