MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-05-14 for MI-1000 061514-V manufactured by Medical Illumination Intrnation Inc..
[145768881]
We received the returned light listed under customer complaint #(b)(4) and imitated an investigation. The product was a mi-1000 single ceiling mount. A visual inspection was performed and other than the arm support fitting (p/n 1002036) there was light surface damage found (ie: nicks and scratches). Because the arm support fitting (1002036) was tested several weeks ago under rma # (b)(4) for another customer complaint (#(b)(4)). The load test was not run again. We did cross-section analysis on the failed surfaces and did not see any porosity or abnormal material flow patterns. We could not definitively determine the cause of the failure. The light surface damage was deemed inconsequential. This are was out of (b)(4) sold in 2014 and this is the only failure of this component reported for that production year. Note: this report is late because it was sent to the test emdr instead of production.
Patient Sequence No: 1, Text Type: N, H10
[145768882]
On (b)(6) 2017 an incident was reported to medical illumination regarding an mi-1000 arm support fitting fracturing causing the light to fall. There were no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028295-2018-00002 |
| MDR Report Key | 8609589 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-05-14 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2014-08-30 |
| 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 | 3 |
| Brand Name | MI-1000 |
| Generic Name | MINOR SURGICAL LIGHT |
| Product Code | FST |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2017-12-01 |
| Model Number | 061514-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 |