MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for MI-1000 DUAL CEILING 061515-V manufactured by Medical Illumination Intrnation Inc..
[145538778]
We received the returned light under customer complaint : (b)(4) and an investigation was initiated. The unit was visually inspected and the arm support fitting (p/n 1002036) was found to have failed. No other damage was observed. Having see a similar failure within the past six months, we performed multiple cut cross-section analysis to rule out porosity as a cause of failure. The material porosity looked normal and no stress-related factors were found. The product could not be capacity tested due to the failure location so it was rebuilt and tested with a p/n 1002036. We then tested the system to the failure analysis of the mi-1000 system dated 07/16/2015. The unit passed all tests. We could not determine the ultimate cause of the failure of the p/n 1002036. The load test was performed at 6x and the unit showed on degradation. Note: this report is late because it was sent to the test emdr instead of production.
Patient Sequence No: 1, Text Type: N, H10
[145538779]
On (b)(6) 2017 an incident was reported to medical illumination regarding an mi-1000 arm support fitting causing the light to fall. There were no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028295-2018-00003 |
| MDR Report Key | 8609840 |
| Date Received | 2019-05-14 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2019-05-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT HESS |
| Manufacturer Street | 547 LIBRARY STREET |
| Manufacturer City | SAN FERNANDO CA 91340 |
| Manufacturer Country | US |
| Manufacturer Postal | 91340 |
| Manufacturer Phone | 8188383025 |
| Manufacturer G1 | MEDICAL ILLUMINATION INTRNATION INC. |
| Manufacturer Street | 547 LIBRARY STREET |
| Manufacturer City | SAN FERNANDO CA 91340 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91340 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MI-1000 DUAL CEILING |
| Generic Name | MINOR SURGICAL LIGHT |
| Product Code | FST |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2018-01-15 |
| Model Number | 061515-V |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ILLUMINATION INTRNATION INC. |
| Manufacturer Address | 547 LIBRARY STREET SAN FERNANDO CA 91340 US 91340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |