MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-16 for OPTIVANTAGE DH 844001 manufactured by Liebel Flarsheim.
[46503077]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[46503078]
The customer reports the equipment has injected the dye independently without any command sent. No additional details were available. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
[46506540]
The equipment has injected the dye independently without any command sent. No patient harm. Regional service was not able to reproduce an (independent injection) error. Service did not see the equipment perform an injection or any other function independently without any command sent. Service replaced the cable from console to injector (15 pos d-shell 3m/10ft cable ass'y, 800113), because the customer had said one time the injector had started to work alone. Unit ok, returned to normal use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2016-00037 |
| MDR Report Key | 5656500 |
| Date Received | 2016-05-16 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-04-18 |
| Date Mfgr Received | 2016-04-18 |
| Device Manufacturer Date | 2010-03-31 |
| Date Added to Maude | 2016-05-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| 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 | 2016-05-16 |
| Model Number | OPTIVANTAGE DH |
| Catalog Number | 844001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-16 |