MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-13 for OPTIVANTAGE DH 844001 manufactured by Liebel-flarsheim.
[174735894]
This incident was reported on 14 december 2019 from a facility in (b)(6) as reporter from facility states that there was air in the aorta of the patient during injection. Technical services seem to suspect a user error and not a malfunction and they have provided user training.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2020-00001 |
| MDR Report Key | 9580697 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-14 |
| Date of Event | 2019-12-14 |
| Date Mfgr Received | 2019-12-14 |
| Device Manufacturer Date | 2011-05-31 |
| Date Added to Maude | 2020-01-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIVANTAGE DH |
| Generic Name | OPTIVANTAGE DH |
| Product Code | IZQ |
| Date Received | 2020-01-13 |
| Model Number | 844001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-13 |