MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2000-04-12 for MEDTRONIC VRV-100 1140333-1 manufactured by Medtronic Cardiopulmonary- Anaheim.
[171557]
The hosp reported that at the end of bypass, the vacuum relief valve failed. The line was replaced with no effect to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022036-2000-00012 |
| MDR Report Key | 274084 |
| Report Source | 05,06,07 |
| Date Received | 2000-04-12 |
| Date of Event | 2000-03-13 |
| Date Facility Aware | 2000-03-13 |
| Date Mfgr Received | 2000-03-13 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2000-04-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 4633 E LAPALMA AVE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7147793651 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC VRV-100 |
| Generic Name | VACUUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 2000-04-12 |
| Returned To Mfg | 2000-06-21 |
| Model Number | 1140333-1 |
| Catalog Number | 1140333-1 |
| Lot Number | 9904002850 |
| ID Number | NA |
| Device Expiration Date | 2001-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 265298 |
| Manufacturer | MEDTRONIC CARDIOPULMONARY- ANAHEIM |
| Manufacturer Address | 4633 EAST LAPALMA AVE. ANAHEIM CA 92807 US |
| Baseline Brand Name | MEDTRONIC VRV-100 |
| Baseline Generic Name | VACUUM RELIEF VALVE |
| Baseline Model No | 1140333-1 |
| Baseline Catalog No | 1140333-1 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-04-12 |