FDA.reportPublic FDA data

MAUDE MDR 353746

MDR report key
353746
Report number
2518435-2001-00003
Event key
0
Event type
3
Date received
2001-09-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JACK HENNE
Address
RT 611 N PLUMSTEADVILLE PA 18949 US
Phone
215-215-2157
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NACALIBRATION GAS STANDARDSCOTT MEDICAL PRODUCTSBXK*536053116617NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-09-280

Event Narratives#

D

Patient 1

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.