CARDIO 2
Received Aug 24, 1999 · Event occurred Aug 20, 1999
Report MW1017024 · MDR key 237117
Device
Generic name
Cardiopulmonary Stress Test Computer & Manual
Manufacturer
Medical Graphics Corp.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Inadequate Instructions for Healthcare Professional
- Application Program Problem: Parameter Calculation Error
- Incorrect Or Inadequate Test Results
Patient
NA
Narrative
Description of Event or Problem
PHYSICIAN RUNNING TEST REQUESTED THAT MANUAL DATA CALCULATIONS BE DONE TO COMPARE AGAINST THE MACHINE'S SOFTWARE. THE RESPIRATORY THERAPIST REFERRED TO THE INSTRUCTION MANUAL FOR THE DEVICE AND FOUND THAT THE MFR HAD LEFT OUT CRITICAL PARENTHESES IN MOST OF THEIR PRINTED FORMULAS. IF USING THIS SET OF FORMULAS, THE USER WOULD MAKE EXTREME ERRORS IN CALCULATIONS WHICH MAY ADVERSELY AFFECT PT CARE. THE RPTR WAS ABLE TO OBTAIN ALTERNATIVE REFERENCES FOR THESE CALCULATIONS, BUT POINTS OUT THAT OTHERS MAY NOT EVEN RECOGNIZE THE ERROR. IT IS UNK WHETHER THE MANUAL CALCULATIONS CHECKED OUT AGAINST THE SOFTWARE DATA. RPTR BELIEVES MFR SHOULD HAVE NOTIFIED ALL OF ITS USERS.