MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-15 for MPS 2 CONSOLE 5201260 manufactured by Quest Medical, Inc..
[136617921]
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.
Patient Sequence No: 1, Text Type: N, H10
[136617922]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00006 |
| MDR Report Key | 8346013 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-15 |
| Date Mfgr Received | 2019-01-23 |
| Date Added to Maude | 2019-02-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 3 |
| Brand Name | MPS 2 CONSOLE |
| Generic Name | CPBP HEAT EXHANGER |
| Product Code | DTR |
| Date Received | 2019-02-15 |
| Model Number | 5201260 |
| Lot Number | 2505 |
| 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 | 2019-02-15 |