MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-09-30 for OPTIVANTAGE BASE SYSTEM OPTVANTAGE BASE SYSTEM V8400 manufactured by Liebel Flarsheim.
[4945054]
Mallinckrot (b)(4) service reports; after installing a pre-filled syringe of 125 ml on the side b, low pressure tubing purged, customer connected the catheter to the patient and then turned powerhead into the injection position, operators returned to the console of the scanner. They checked the injection protocol, but did not enable or start the program. While they were working on setting the scanner protocol, they heard beep from the console of the injector. It displayed a red box with the error code 1008-the console loses communication packets from the powerhead for more than 2 seconds, on the console screen, above-the red box. The volume indicated syringe of the side b decreased as during an injection. They tried to stop the injection without success and launched the acquisition mode of the scanner. At the end of the acquisition, they entered the room, found the syringe was partially empty and the screen of the powerhead displayed numbers 0x002, 0x005, error code 2005-powerhead touch screen failure. Customer reported there was no injury to the patient. After switching off and on the injector, it started normally. They reused immediately for the next patient. On (b)(6): service reports: this is a reportable event. Can you please provide the following information; patient outcome. Is the patient ok? No patient injury. Patient gender and age, we can't communicate this information in (b)(4). How was the patient treated, no specific treatment. Type of procedure being completed,? Injection protocol, 110ml @ 1,8 ml/s. Type of contrast being used, optijet. Any other information you feel is important to this event.
Patient Sequence No: 1, Text Type: D, B5
[12422183]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[28930625]
Regional service couldn't reproduce the error, but noted error codes in memory. Service replaced the powerhead board, calibrated the unit, tested it, and released the unit for use. History review shows no other similar issues with this unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2014-00119 |
| MDR Report Key | 4128340 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-09-30 |
| Date of Report | 2015-01-06 |
| Date of Event | 2014-09-04 |
| Date Mfgr Received | 2014-09-04 |
| Device Manufacturer Date | 2011-11-30 |
| Date Added to Maude | 2014-10-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Manufacturer G1 | LIEBEL FLARSHEIM |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIVANTAGE BASE SYSTEM |
| Generic Name | 74 IZQ |
| Product Code | IZQ |
| Date Received | 2014-09-30 |
| Model Number | OPTVANTAGE BASE SYSTEM |
| Catalog Number | V8400 |
| 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 | 2123 EAST GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-30 |