MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-30 for ILUMIEN OPTIS SYSTEM C408650 manufactured by St. Jude Medical.
[91207364]
The ilumien optis system started up normally in preparation for a procedure. When attempting to enter the patient details, a loud bang was heard from the back of the system. The system was smoking and sparks were seen at the socket. The system was immediately shut down and removed from the lab. It has not been used since. The wall socket was inspected but the only thing observed was a tripped breaker. The patient procedure was completed without the system with no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2017-00007 |
| MDR Report Key | 6987282 |
| Date Received | 2017-10-30 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-10-09 |
| Date Mfgr Received | 2017-12-14 |
| Date Added to Maude | 2017-10-30 |
| 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 | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 4 ROBBINS DRIVE |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01886 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILUMIEN OPTIS SYSTEM |
| Generic Name | IMAGING SYSTEM |
| Product Code | NQQ |
| Date Received | 2017-10-30 |
| Model Number | C408650 |
| Catalog Number | C408650 |
| ID Number | 00183739000678 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-30 |