MalfunctionCCE
ABL700 SERIES
Received May 31, 2007 · Event occurred Apr 30, 2007
Report 3002807968-2007-00008 · MDR key 859478
Device
Product problems
- Computer hardware error
- False Reading From Device Non-Compliance
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DATA FROM A BLOOD SAMPLE ANALYZED ON AN BLOOD GAS ANALYZER WAS DISPLAYED CORRECTLY ON THE MONITOR AND TRANSFERRED CORRECTLY TO RADIANCE. HOWEVER, THE NEXT 10 PRINT-OUTS WAS ALL INCLUDING THE DATA OF THIS SAMPLE. THE REPEATED PRINT-OUT OF THE SAME SAMPLE COULD HAVE RESULTED IN MIX-UP OF PATIENT DATA. THE OPERATOR NOTICED THE MISTAKE AND NO PATIENTS WERE MISTREATED AS A RESULT. AT PRESENT, THE CAUSE OF THE INCIDENT IS NOT CLEAR. INVESTIGATION IS CONTINUES.