MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-15 for C8I ? OCT INTEGRATED SYSTEM C408652 manufactured by St. Jude Medical.
[166571650]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[166571651]
After a power surge in the hospital, an audible "bang" occurred and smoke was noted to be coming from the system. There was intermittent angio co-registration feed resulting in grainy images being displayed. The hospital experienced a power surge and the system became unable to function properly. The fuses were replaced and the kit was attempted to be booted, but an audible "bang" occurred and the system would no longer power up. Smoke was noted to be coming from the system. There was no patient involved in this event. After investigation, the power supply unit fuses were found to be blown. The fuses were replaced and the issue was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2019-00027 |
| MDR Report Key | 9328659 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-15 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2019-10-31 |
| Device Manufacturer Date | 2018-11-27 |
| Date Added to Maude | 2019-11-15 |
| 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 | STEPHANIE O' SULLIVAN |
| 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 | 3 |
| Brand Name | C8I ? OCT INTEGRATED SYSTEM |
| Generic Name | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) |
| Product Code | NQQ |
| Date Received | 2019-11-15 |
| Model Number | C408652 |
| Lot Number | 6802647 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-11-15 |