MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for OPTIVANTAGE WITH PEDESTAL V8401 manufactured by Liebel-flarsheim.
[66003500]
The equipment is starting the injections by itself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2017-00002 |
| MDR Report Key | 6275805 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-25 |
| Date of Event | 2017-01-09 |
| Date Mfgr Received | 2017-01-09 |
| Device Manufacturer Date | 2007-11-30 |
| Date Added to Maude | 2017-01-25 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E GALBRAITH RD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTIVANTAGE WITH PEDESTAL |
| Generic Name | OPTIVANTAGE WITH PEDESTAL |
| Product Code | IZQ |
| Date Received | 2017-01-25 |
| Model Number | V8401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E GALBRAITH RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-25 |