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..
[139822986]
The device was evaluated and he reported ec004 was not duplicated and the log data could not be retrieved. In the console ten codes of ec284 was found. A wet lab was performed and the ec284 was duplicated. The fluid level sensor was removed and replaced. After the replacement, f6 software was reinstalled to clear and remove the corrupted files. Mps console was then tested and passed the operational verification test. The root cause of the reported ec004 is unknown.
Patient Sequence No: 1, Text Type: N, H10
[139822987]
A report was received regarding an alleged issue encountered during use of the console. The report states that during a case, the console displayed ec004. The user power cycled a few times where the message was observed after each power cycle. The console was turned off and on again and this resolved the issue. There were no reported patient complications resulting from the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00016 |
| MDR Report Key | 8446288 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date Mfgr Received | 2019-03-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Lot Number | 3017 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 |
| Lot Number | 3017 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 |