FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC VRV-100
MDR report key: 272946
·
Received April 3, 2000
Report
- Report Number
- 2022036-2000-00010
- Event Type
- Malfunction
- Date Received
- April 3, 2000
- Date of Event
- March 1, 2000
- Report Date
- March 31, 2000
- Manufacturer
- MEDTRONIC CARDIOPULMONARY-ANAHEIM
- Product Code
- MNJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE HOSP REPORTED THAT THE VACUUM RELIEF VALVE LEAKED DURING USE. THE VACUUM RELIEF VALVE WAS CHANGED OUT WITH NO AFFECT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC VRV-100 | VACUUM RELIEF VALVE | MNJ | MEDTRONIC CARDIOPULMONARY-ANAHEIM | 1140333-1 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |