FDA Adverse Event
Malfunction
Summary report: N
TRITON CANISTER
MDR report key: 20305214
·
Received September 25, 2024
Report
- Report Number
- 3015967359-2024-01842
- Event Type
- Malfunction
- Date Received
- September 25, 2024
- Date of Event
- August 26, 2024
- Report Date
- July 7, 2025
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- PBZ
- UDI-DI
- 00859506006029
- PMA / PMN Number
- K163507
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
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 · 0
DURING A PROCEDURE WITH HEMORRHAGING, THE QUANTITATIVE BLOOD LOSS WAS SIGNIFICANTLY LOWER THAN THE ESTIMATED BLOOD LOSS ON THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Description of Event or Problem · 0
NO NEW INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1303968 | TRITON CANISTER | IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS | PBZ | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | 00859506006029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |