RAPIDPOINT 400
Received Mar 30, 1999 · Event occurred Mar 18, 1999
Report 1217157-1999-00002 · MDR key 217078
Device
Generic name
Blood Gas Analyzer
Manufacturer
Chiron Diagnostics Corp.Model number
NACatalog number
109824
Lot number
NA
Product problems
- Computer Software Problem
- Output above Specifications
Patient
NA
Narrative
Description of Event or Problem
A STEP INCREASE IN THE SIGNAL OUTPUT OF THE PARTIAL OXYGEN PRESSURE SENSOR FOR THE RAPIDPOINT 400 SENSOR MAY OCCUR. DEPENDING ON THE SLOPE DETERMINED AT SCHEDULE (EVERY 30 MINUTES) CALIBRATION, THE ABSOLUTE PARTIAL PRESSURE OF OXYGEN VALUE COULD BE REPORTED HIGHTER THAN THE ACTUAL PT VALUE. THE RAPIDPOINT 400 SOFTWARE IS DESIGNED TO DETERMINE THE DIFFERENCE IN OUTPUT BETWEEN WASHES BEFORE OR AFTER CONSECUTIVE PT SAMPLES AND FLAG ANY ANALYTICAL PARTIAL PRESSURE OF OXYGEN RESULTS WHICH MANIFESTS IN A SIGNAL OF 0.5NA(NANOAMPERE) OR GREATER. HOWEVER, SIGNAL DIFFERENCES BELOW 0.5NA ARE NOT FLAGGED. NO SERIOUS INJURIES OR DEATH IS ASSOCIATED WITH THIS EVENT. INITIAL REPORT OF THIS EVENT WAS AS A RESULT OF EVALUATION OF INTERNAL TESTING.
Remedial action
- Recall