MalfunctionLWH
SC+ QBL SOFTWARE
Received May 8, 2025 · Event occurred Apr 14, 2025
Report 3015967359-2025-01002 · MDR key 21987728
Device
Generic name
Image Processing Device For Estimation Of External Blood Loss
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0894-000-005
Product problems
- High Readings
- High Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PER THE USER FACILITY, THE DEVICE DISPLAYED READINGS HIGHER THAN EXPECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
UPDATE: D9, H3, H6. CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE LOG FILES WERE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem
NO NEW INFORMATION.