MEDICAL GAS YOKE ASSEMBLY

Additional Manufacturer Narrative

THE UNIT INVOLVED IN THIS EVENT WAS MANUFACTURED AND DISTRIBUTED BY (B)(4). (B)(4) IS SUBMITTING ITS OWN MDR FOR THIS EVENT. HOWEVER, PURSUANT TO A PRE-EXISTING WRITTEN AGREEMENT BETWEEN AIRGAS AND (B)(4), AIRGAS IS SUBMITTING THIS MDR. AS THE MFR OF THE YOKE ASSEMBLIES, (B)(4) IS RESPONSIBLE FOR THE INVESTIGATION OF THE UNDERLYING EVENT. TO ADDRESS THIS MATTER AND REMEDY TO SITUATION, (B)(4) 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. AIRGAS IS RETRIEVING AND REPLACING ALL OF THE MANIFOLD BLOCK ASSEMBLIES WHICH ARE COMPONENTS OF THE TWO (2) AND FOUR (4) CYLINDER PORTABLE MANIFOLD CART THAT ARE DISTRIBUTED UNDER THE FOLLOWING PART NUMBER: (B)(4) PORTABLE 2-CYLINDER MANIFOLD CART. PLEASE SEE REPORT#: 1526809-2009-00002.

Description of Event or Problem

AIRGAS RECEIVED A REPORT OF A POTENTIAL NONCONFORMITY INVOLVING THE MEDICAL GAS YOKE ASSEMBLIES THAT ARE COMPONENTS OF THE MANIFOLD BLOCK ASSEMBLIES ON PORTABLE 2-CYLINDER AND 4-CYLINDER MANIFOLD CARTS THAT ARE SOLD BY AIRGAS. AIRGAS WAS MADE AWARE BY THE MFR OF THE MANIFOLD CARTS, WESTERN/SCOTT FETZER, THAT IN CERTAIN USE SITUATIONS, AND IN COMBINATION WITH VARIOUS FACTORS, THE YOKE PINS MAY BECOME DISPLACED TO SUCH A DEGREE THAT A POST VALVE OF ONE GAS TYPE COULD BECOME INTERCHANGEABLE WITH A YOKE CONNECTION OF ANOTHER GAS TYPE (I.E., AN OXYGEN CYLINDER BECOME ATTACHED TO A NITROUS OXIDE YOKE). SHOULD THIS CONDITION OCCUR, THE YOKE INDEX SAFETY SYSTEM COULD BECOME COMPROMISED AND THE POTENTIAL EXISTS FOR A USER TO ATTACH THE WRONG GAS TYPE TO THE YOKE CONNECTION. TO DATE, AIRGAS HAS NOT RECEIVED ANY REPORTS OF SUCH AN IMPROPER CONNECTION OR ANY REPORTS OF A PT BEING EXPOSED TO AN INCORRECTLY-CONNECTED MEDICAL GAS SYSTEM.