MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for MPS 2 CONSOLE 5201260 manufactured by Quest Medical, Inc..
[139822900]
The device is expected to be returned to quest medical for evaluation. A follow-up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[139822901]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00018 |
| MDR Report Key | 8446286 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TOSAN ONOSODE |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MPS 2 CONSOLE |
| Generic Name | CPBP HEAT EXHANGER |
| Product Code | DTR |
| Date Received | 2019-03-22 |
| Model Number | 5201260 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Brand Name | MPS 2 CONSOLE |
| Generic Name | CPBP HEAT EXHANGER |
| Product Code | DTR |
| Date Received | 2019-03-22 |
| Model Number | 5201260 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |