FDA Adverse Event
Malfunction
Summary report: N
RAPIDPOINT 400
MDR report key: 217078
·
Received March 30, 1999
Report
- Report Number
- 1217157-1999-00002
- Event Type
- Malfunction
- Date Received
- March 30, 1999
- Date of Event
- March 18, 1999
- Report Date
- March 18, 1999
- Manufacturer
- CHIRON DIAGNOSTICS CORP.
- Product Code
- CCC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDPOINT 400 | BLOOD GAS ANALYZER | CCC | CHIRON DIAGNOSTICS CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |