MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for RLV-2100 VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc.
[93809294]
At the time of this report, the device has not been returned for investigation. A follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[93809295]
A customer reported a leakage on the valve that occurs when pressure rises above 100mmhg. The leakage was identified during priming. There were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
[132400905]
The device was evaluated through simulated use testing and it functioned as intended. No leak was observed. The device is intended to relieve pressure at negative pressure of -200mmhg and positive pressure build up of <1300mmhg (avg). A dhr review was conducted and no anomalies were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2017-00099 |
| MDR Report Key | 7064305 |
| Date Received | 2017-11-28 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2017-11-10 |
| Date Added to Maude | 2017-11-28 |
| 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 |
| 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 | RLV-2100 VACUUM RELIEF VALVE |
| Generic Name | CARDIOPULMONARY SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2017-11-28 |
| Returned To Mfg | 2018-01-17 |
| Model Number | 4103202 |
| Catalog Number | 4103202 |
| Lot Number | 050997 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-11-28 |