MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2019-05-15 for MI-1000 061515 manufactured by Medical Illumination Intrnation Inc..
[145946718]
The lighting system was installed in a vertinarians examination room with normal use and no extreme instances reported. The arm support fitting component (p/n 1002036) was not available to the engineering group to perform a root cause analysis so the following assumptions of the failure are derived only from the pictures supplied from the customer. The pictures show several things pertinent to the failure. The material appears to be solid and null of any voids indication that there was no porosity or material breakdown. The material appears to be consistent in color with virgin raw aluminum material - no contamination observed. The break appears to be consistent and straight indicating that this likely happened instantaneously and not over a period of time. The breaking point is located at the through hole on the arm pivot point. This could also be consistent with a sudden impact of the arm assembly to a solid or hard object but this speculation cannot be fully substantiated from a photograph. In researching this failure we found two (2) other reported field failures with similar visual indications. One of the failures was a result of a hard impact against a wall and the other failure occurred when a medical technician admittedly over-tightening the pivot screw. Both incidents were deemed operator caused. It is impossible to definitively assign cause to this analysis because we do not have the physical component that failed. It is also speculation that this component operated normally within specified range of normal operation. Note: this report is late because it was sent to the test emdr instead of production. This issue has been resolved.
Patient Sequence No: 1, Text Type: N, H10
[145946719]
On (b)(6) 2019 it was reported to medical illumination that a mi-1000 had a broken arm support fiting p/n 1002036 and was sent in to be repaired. No injuries occured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028295-2019-00001 |
| MDR Report Key | 8614077 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2019-05-15 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2019-05-15 |
| 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 | 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 | 2019-05-15 |
| Returned To Mfg | 2019-02-04 |
| Model Number | 061515 |
| 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 | 2019-05-15 |