MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-29 for OMNI VALVE MEDICAL GAS VALVE INTEGRATED PRESSURE REGULATOR manufactured by Harrison/cramer Decker.
[71528945]
Harrison omni valve medical gas valve integrated pressure regulator: various issues related to the apparent failure/malfunction of regulator components during the filling process at the gas plant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068806 |
| MDR Report Key | 6450715 |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-29 |
| Date Added to Maude | 2017-03-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OMNI VALVE MEDICAL GAS VALVE INTEGRATED PRESSURE REGULATOR |
| Generic Name | OMNI VALVE MEDICAL GAS VALVE INTEGRATED PRESSURE REGULATOR |
| Product Code | ECX |
| Date Received | 2017-03-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARRISON/CRAMER DECKER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-29 |