MalfunctionCCM
MEDGRAPHICS
Received Jan 14, 1998
Report 148756 · MDR key 148756
Device
Generic name
Body Plethysmograph With Diffusing Capacity
Manufacturer
MedgraphicsModel number
1085-DCatalog number
NI
Lot number
NI
Product problems
- Measurements, inaccurate
- Blood gas measurements, erroneous
- Low Readings
Patient
NA
Narrative
Description of Event or Problem
IN 2/97, THREE MEDGRAPHICS 1085 ADVANTAGE PLUS SYSTEMS WERE PURCHASED BY MEDICAL CENTER TO REPLACE THE OLDER 1070 MODELS. IN 6/97, IT WAS NOTED THAT THE 1085 WAS PRODUCING COMPARATIVE DIFFUSION READINGS 5-10% LOWER THAN THE 1070. IN 11/97, G.C. COLUMNS WERE REPLACED IN THE THREE 1085 UNITS. THE 1085 UNITS CONTINUED TO PRODUCE RESULTS THAT WERE LOWER THAN THE 1070 BEYOND THE ACCEPTABLE VARIATION (6%).