N
Patient 1
THE DEVICE IS EXPECTED TO BE RETURNED TO QUEST MEDICAL FOR EVALUATION. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
MAUDE MDR 8446290
- MDR report key
- 8446290
- Report number
- 1649914-2019-00017
- Event key
- 0
- Event type
- 3
- Date received
- 2019-03-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- 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 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-22 | 0 |
Event Narratives#
D
Patient 1
A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE ENCOUNTERED WITH THE CONSOLE. THE REPORT STATES THAT THE CONSOLE DISPLAYED EC179. THERE WERE NO REPORTED PATIENT COMPLICATIONS.