MalfunctionPBZ
SURGICAL TABLET 3.0
Received Jan 6, 2025 · Event occurred Dec 10, 2024
Report 3015967359-2025-00019 · MDR key 21087360
Device
Generic name
Image Processing Device For Estimation Of External Blood Loss
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0894-001-000
Product problems
- Low Readings
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATE: H3, H6. DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE EVALUATION.
Description of Event or Problem
NO NEW INFORMATION.
Description of Event or Problem
PER THE USER FACILITY, CANISTER VOLUMES WERE LOWER THAN EXPECTED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.