MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-31 for HARMONY LED manufactured by Steris Corporation.
[58736682]
Patient Sequence No: 1, Text Type: N, H10
[58736683]
This happened in our surgical operating room. Steris harmony led ceiling mounted surgical lights found to be rusted. Cleaning solution is running down the arm and getting trapped under the service collar that covers the break screws near the head light. These fluids are rusting the lights.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6066270 |
| MDR Report Key | 6066270 |
| Date Received | 2016-10-31 |
| Date of Report | 2016-10-13 |
| Date of Event | 2016-09-27 |
| Report Date | 2016-10-11 |
| Date Reported to FDA | 2016-10-11 |
| Date Reported to Mfgr | 2016-10-11 |
| Date Added to Maude | 2016-10-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARMONY LED |
| Generic Name | LIGHT, SURGICAL, CEILING MOUNTED |
| Product Code | FSS |
| Date Received | 2016-10-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-31 |