MalfunctionCCE
ABL800 SERIES
Received May 24, 2007 · Event occurred Apr 23, 2007
Report 3002807968-2007-00007 · MDR key 859481
Device
Product problems
- Device Alarm System
- High Test Results
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE ABNORMALLY HIGH PO2 VALUES ARE CLOSE TO THE VALUES OF ATMOSPHERIC AIR WHICH SUGGESTS, THAT AIR-BUBBLES HAS BEEN INTRODUCED INTO THE SAMPLES, AND THAT THE MEASUREMENTS MAY HAVE BEEN CONDUCTED ON THE SECLUDED AIR.
Description of Event or Problem
WHEN MEASURING PO2 ON THE BLOOD GAS ANALYZER WITH FLEXQ, A PHYSICIAN CONSIDERED THAT THE OBTAINED PO2 VALUES TO BE ABNORMALLY HIGH. THIS WAS CONFIRMED BY NEW MEASUREMENTS. NO ALARM WAS ISSUED. THE VALUES WERE CLOSE TO THE VALUES OF ATMOSPHERIC AIR WERE OBTAINED. THERE HAS BEEN NO INFORMATION OF SERIOUS INJURY IN THE REPORTED INFORMATION.