MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-04-03 for MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE VRV-100 TL4E38R2 manufactured by Medtronic Perfusion Systems.
[17030989]
The valve leaked during bypass in a vent application. The unit was replaced during the case with no patient complication reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2006-00028 |
| MDR Report Key | 696659 |
| Report Source | 05,07 |
| Date Received | 2006-04-03 |
| Date of Report | 2006-03-10 |
| Date of Event | 2006-03-10 |
| Date Facility Aware | 2006-03-10 |
| Report Date | 2006-03-10 |
| Date Reported to Mfgr | 2006-03-10 |
| Date Mfgr Received | 2006-03-10 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-04-10 |
| 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 | LISA WEIK |
| Manufacturer Street | 8299 CENTRAL AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635146694 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE |
| Generic Name | VACUUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 2006-04-03 |
| Returned To Mfg | 2006-03-15 |
| Model Number | VRV-100 |
| Catalog Number | TL4E38R2 |
| Lot Number | 3265856 |
| ID Number | NA |
| Device Expiration Date | 2007-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNK |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 685767 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Baseline Brand Name | VACUUM RELIEF VALVE |
| Baseline Generic Name | VACUUM RELIEF VALVE |
| Baseline Model No | VRV-100 |
| Baseline Catalog No | 1140333-1 |
| Baseline ID | NA |
| Baseline Device Family | VACUUM RELIEF VALVE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K953564 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-04-03 |