RAPIDLAB 348
Received Jan 27, 2015 · Event occurred Nov 6, 2014
Report 1217157-2015-00011 · MDR key 4457174
Device
Generic name
Rl 348
Catalog number
10318140
Product problems
- Low Test Results
- Device Displays Incorrect Message
- Device Sensing Problem
- Patient Data Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT SYSTEM DID NOT DISPLAY AN ERROR WHEN BAROMETRIC PRESSURE SENSOR NOT WORKING. CUSTOMER ALSO REPORTED FALSELY LOW PO2 AND PCO2 ON THE INSTRUMENT. CUSTOMER INDICATED THAT INCORRECT DATA WERE REPORTED WITH 7 PATIENTS. THERE WAS NO HARM TO THE PATIENT OR OPERATOR DUE TO THIS EVENT.
Additional Manufacturer Narrative
CUSTOMER INDICATED THAT NO MEDICAL PROCEDURE OR TREATMENT GOT DELAYED DUE TO THIS EVENT. CUSTOMER ALSO INDICATED THAT THEY DID NOT MEASURE QUALITY CONTROL (QC) AS A DAILY ROUTINE. CUSTOMER SHOULD NOT HAVE RUN PATIENT SAMPLES WITHOUT RUNNING QUALITY CONTROL. CUSTOMER INDICATED THAT ISSUE HAS BEEN RESOLVED WITH THE REPLACEMENT OF THE BAROMETRIC PRESSURE SENSOR.