MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for lITHONIA LIGHTING FROM INTEGRASEAL LENS SYAR 2SRT manufactured by Lithonia Lighting/acuity Brands Lighting.
[134917497]
The lens in the lithonia light fixtures suitable for use in iso 7 and iso 8 cleanrooms and surgical suites were placed in the lens frame upside down thus exposing the radio interference filter (rif) to disinfectant cleaning solutions during our scheduled monthly wall and ceiling washing. The rif immediately started to degrade and flake off upon contact with our cleaner disinfectant (oxivir tb). This resulted in a shutdown of our surgery suite until repeat terminal cleaning was done. Upon further inspection of the light lens, it was found that lens was not consistently placed in the frame by the manufacturer. Some lenses had the rif exposed outside of the light fixture while others had the rif facing inside the light fixture thus protecting it from the cleaning chemicals. This is a manufacturing flaw that is not easily detected. The lens is placed into the frame by the manufacturer and there is only one way to install the lens frame into the fixture. Product specific information: integra seal cleanroom lighting - lithonia lighting 2srt recessed clean room troffer 2x4; grid 1-1/2 inch wide tee, number of lamps 6; lamp type 32w t8 (48? ) door - fw aluminum insert white, lens syar psi symmetric/asymmetric acrylic with radio filter grid 200? Thick; ballast geb1015, internal fast blow fuse, rif radio interference filter (one per fixture).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083539 |
| MDR Report Key | 8292808 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-28 |
| Date of Event | 2019-01-18 |
| Date Added to Maude | 2019-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | lITHONIA LIGHTING FROM INTEGRASEAL |
| Generic Name | LIGHT, SURGICAL HEADLIGHT |
| Product Code | EBA |
| Date Received | 2019-01-29 |
| Model Number | LENS SYAR |
| Catalog Number | 2SRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LITHONIA LIGHTING/ACUITY BRANDS LIGHTING |
| Manufacturer Address | CONYERS GA 30012 US 30012 |
| Brand Name | LITHONIA LIGHTING FROM INTEGRASEAL SURGERY LIGHT FIXTURE |
| Generic Name | LIGHT, SURGICAL HEADLIGHT |
| Product Code | EBA |
| Date Received | 2019-01-29 |
| Model Number | LENS SYAR |
| Catalog Number | 2SRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRASEAL/ACUITY LIGHTING GROUP, INC. |
| Manufacturer Address | CONYERS GA 30012 US 30012 |
| Brand Name | LITHONIA LIGHTING FROM INTEGRASEAL SURGERY LIGHT FIXTURE |
| Generic Name | LIGHT, SURGICAL HEADLIGHT |
| Product Code | EBA |
| Date Received | 2019-01-29 |
| Model Number | LENS SYAR |
| Catalog Number | 2SRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | INTEGRASEAL/ACUITY LIGHTING GROUP, INC. |
| Manufacturer Address | CONYERS GA 30012 US 30012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-29 |