MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-04 for DEEPSITE LIGHT CONNECTED TO HARMONY LA500 LIGHTING SYSTEM manufactured by Steris Corporation - Montgomery.
[123514441]
The deepsite light was installed in july of 2008 and is approximately 10 years old. The light is not under steris service agreement for maintenance activities. A steris service technician arrived onsite to inspect the deepsite lighthead and identified the user facility utilizes diversey virex ii disinfectant cleaner for cleaning and disinfecting the lighting system. Diversey virex ii disinfectant cleaner has not been tested for compatibility or effectiveness with the materials in the light as stated in the operator manual. The operator manual states (pg. 6-1), "caution-possible equipment damage hazard: use of any disinfectant solution other than those listed here may cause discoloration or deformation: germicidal surface wipes disinfecting/deodorizing/ cleaning wipes. Cleaning solutions other than those listed have not been tested for compatibility or effectiveness. Always follow manufacturer instructions for concentrations and use of cleaning products. " additionally, the operator manual states (pg. 6-1), "caution-possible equipment damage hazard: cleaning and disinfecting agents used on this lighting system must be certified by their manufacturer to be compatible with the following material: polycarbonate, polyetherimide, santoprene" and "do not spray any cleaning product directly onto the lighthead, modem chassis, or any system components. " the technician counseled user facility personnel on the proper use and operation of the light and the importance of proper cleaning practices.
Patient Sequence No: 1, Text Type: N, H10
[123514442]
The user facility reported that during a patient procedure paint was "chipping" from their deepsite lighthead connected to the harmony la500 lighting system. The paint did not fall into the sterile field and the case was completed successfully. No report of injury or procedure delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2018-00078 |
| MDR Report Key | 7936419 |
| Date Received | 2018-10-04 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-10-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEEPSITE LIGHT CONNECTED TO HARMONY LA500 LIGHTING SYSTEM |
| Generic Name | DEEPSITE LIGHT |
| Product Code | FST |
| Date Received | 2018-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-04 |