N
Patient 1
THE DEVICE WAS EVALUATED AND THE FLUID LEVEL SENSOR WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED COMPLAINT CONDITION. THE FLUID LEVEL SENSOR WAS REPLACED AND THE CONSOLE PASSED ALL OPERATIONAL VERIFICATION TESTS.
MAUDE MDR 8346013
- MDR report key
- 8346013
- Report number
- 1649914-2019-00006
- Event key
- 0
- Event type
- 3
- Date received
- 2019-02-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- TOSAN ONOSODE
- Address
- ONE ALLENTOWN PARKWAY ALLEN TX 75002 US
- Phone
- 972-972-9723
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MPS 2 CONSOLE | CPBP HEAT EXHANGER | QUEST MEDICAL, INC. | DTR | 5201260 | 2505 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-15 | 0 |
Event Narratives#
D
Patient 1
A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE ENCOUNTERED DURING USE OF THE CONSOLE. THE REPORT STATES THAT DURING A CASE THE CONSOLE STARTED POPPING THE VENT VALVE PROMPTING THE USER TO EITHER DISABLE THE SENSOR OR CONTINUE TO USE AS IS. THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE.