BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL GAS YOKE ASSEMBLY

    MDR report key: 1473070 · Received August 8, 2009

    Report

    Report Number
    1526809-2009-00001
    Event Type
    Malfunction
    Date Received
    August 8, 2009
    Report Date
    August 7, 2009
    Manufacturer
    WESTERN / SCOTT FETZER COMPANY
    Product Code
    CAM
    Removal / Correction Number
    1526809-8/7/09-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NITROUS OXIDE YOKE ASSEMBLY WAS RETURNED. THE RIGHT INDEX PIN WAS PUSHED INWARD APPROX. .093 INCHES AND WAS PROTRUDING FROM THE BACK OF THE YOKE BODY. THE YOKE PIN HOLES EXTEND THROUGH THE BACK OF THE YOKE BODY IN THESE MODELS. TESTING OF SAMPLES FOUND THE YOKE PINS CAN BE PUSHED INWARD BACK THROUGH THE YOKE BODY WITH TORQUES APPLIED TO THE YOKE SCREW IN THE RANGE OF 6-15 FT-LBS. THIS TORQUE IS 2 - 2 1/2 TIMES GREATER THAN THE TORQUE THAT CAN BE GENERATED WITH THE YOKE SCREW SUPPLIED WITH THE ASSEMBLY. INVESTIGATION REVEALED VARIOUS CUSTOMER USE PRACTICES THAT MAY CONTRIBUTE TO THE APPLICATION OF TORQUES THAT MAY EXCEED THOSE INTENDED OR TYPICALLY NEEDED TO ACHIEVE A SEAL AND WHICH MAY EXCEED THE FORCE REQUIRED TO DISPLACE THE PINS. MISMATCHING GAS TYPES BETWEEN POST VALVE AND YOKE AN/OR MISALIGNMENT BETWEEN THE TWO, USE OF DIFFERENT STYLE YOKE SCREWS OTHER THAN THE STYLE SUPPLIED AND/OR USE OF TOOLS TO TIGHTEN THE YOKE SCREW CONNECTION, USE OF DIFFERENT YOKE SEAL WASHERS OTHER THAN THE STYLE SUPPLIED WITH THE ASSEMBLY, WHICH MAY REQUIRE INCREASINGLY HIGHER TORQUE TO ACHIEVE A GAS TIGHT SEAL. ALTHOUGH THE OCCURRENCE WAS CONSIDERED REMOTE, WESTERN IS PERFORMING A RECALL OF AFFECTED PRODUCT. WESTERN HAS DESIGNED A BACK-UP PLATE TO BE INSTALLED BETWEEN THE MEDICAL GAS YOKE ASSEMBLY AND THE MANIFOLD BLOCK TO WHICH IT IS ATTACHED. ONCE INSTALLED, THE BACK-UP PLATE SERVES AS A POSITIVE STOP FOR THE YOKE PINS PREVENTING THEM FROM BEING DISPLACED AND THEREBY MAINTAINING THE INTEGRITY OF THE YOKE PIN INDEX SAFETY SYSTEM. WESTERN HAS NOT RECEIVED ANY REPORTS OF SUCH AN IMPROPER CONNECTION NOR ANY REPORTS OF A PATIENT BEING EXPOSED TO AN INCORRECTLY-CONNECTED MEDICAL GAS SYSTEM. (B)(4).

    Description of Event or Problem · 1

    DURING INSTALLATION OF PORTABLE EQUIPMENT IN A DENTAL CLINIC, IT WAS DISCOVERED BY A MEDICAL GAS VERIFIER THAT THE YOKE INDEX PINS CAN BE PUSHED OUT OF THE YOKE BODY IF THE WRONG GAS CYLINDER IS INSTALLED. THIS MAY COMPROMISE THE PIN INDEX SAFETY SYSTEM OF THE YOKE CONNECTION BY PERMITTING THE CONNECTION OF A GAS CYLINDER POST VALVE OF ONE GAS TYPE TO A YOKE CONNECTION OF ANOTHER GAS TYPE. THE PROBLEM WAS SPOTTED BEFORE THE UNIT WAS USED FOR TREATMENT. WESTERN HAS NOT RECEIVED ANY REPORTS OF SUCH AN IMPROPER CONNECTION NOR ANY REPORTS OF A PATIENT BEING EXPOSED TO AN INCORRECTLY-CONNECTED MEDICAL GAS SYSTEM. THUS, THERE HAVE BEEN NO PATIENT INJURIES ASSOCIATED WITH THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL GAS YOKE ASSEMBLY CAM WESTERN / SCOTT FETZER COMPANY 8066-910

    Patients

    Seq Age Sex Outcome Treatment
    1