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Description of Event or Problem

MEDICAL GRAPHICS CORP'S (MGC) "QA/RA" MGR, CONTACTED SCOTT MEDICAL PRODUCTS' QUALITY ENGINEER TO REPORT A PROBLEM WITH A CALIBRATION GAS STANDARD. BASED ON AN EQUIPMENT SERVICE CALL AT THE USER FACILITY, MGC HAD DETERMINED THAT A CALIBRATION GAS STANDARD, LOT NO. 116617, WAS DEFECTIVE. THE CALIBRATION GAS STANDARD WAS LABELED AS 21% OXYGEN, HOWEVER IT WAS DETERMINED TO BE APPROXIMATELY 19.7% OXYGEN. MGC WAS CALLED TO SERVICE THE CARDIO2 EQUIPMENT (CARDIOPULMONARY EXERCISE SYSTEM) BECAUSE THE PULMONARY GROUP BELIEVED THAT IT WAS NOT PROVIDING CORRECT VO2 VALUES. SMP ANALYZED A CYLINDER FROM THE SAME MANUFACTURING LOT AND CONFIRMED THE VALUE OF THE OXYGEN CONCENTRATION TO BE APPROX 19.7%. MGC COMPLETED EXPERIMENTS TO DETERMINE THE IMPACT OF USING THE 19.7% OXYGEN CALIBRATION GAS ON THE VO2 VALUES. MGC FOUND THE VALUES OF THE VO2 TO BE APPROX 21% HIGHER THAN THE "TRUE" VALUE.