MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-11 for PANORAMIC 200 OPHTHALMOSCOPE P200 A1021 manufactured by Optos Plc.
[1163672]
Patient had a visual field red stimulus and retinal exam. The following day, the patient phoned the site to say that he had a headache, photophobia, persistent after image and described a 'veil over his vision'. Follow up checks on the patient did not reveal any problem but the patient has stated his symptoms persist.
Patient Sequence No: 1, Text Type: D, B5
[8461614]
Optos plc is submitting this mdr as the manufacturer of the subject device and on behalf of the initial importer/distributor, optos inc. Results: (other) optos service engineer visited site in 2009. It was confirmed the device started up as expected. Laser power was measured and found to be 1472 micro watts. This is within specification which has a maximum allowable power at the point of manufacture of 1850 micro watts. This demonstrates the device was operating at class i at the eye for laser power, a classification that is considered non hazardous. The field service engineer also demonstrated that the safety system shut the device down when a fault condition was invoked (this included shutter remaining open when it should be closed and laser scanning speed too slow). Consideration was also given to the led projection system for patient fixation. The emission from this system does not pose any photobiological hazard as per the criteria given in (photobiological safety of lamps and lamp systems). It is concluded that the device is within specification. Optos is exercising an abundance of caution, in that it is reporting this event given the patient statements. However, no contributory factor has been discovered which relates to the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617167-2009-00001 |
| MDR Report Key | 1402091 |
| Report Source | 05 |
| Date Received | 2009-06-11 |
| Date of Report | 2009-05-14 |
| Date of Event | 2009-04-13 |
| Date Mfgr Received | 2009-05-14 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2009-06-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT TWEEDLIE |
| Manufacturer Street | QUEENSFERRY HOUSE CARNEGIE BUSINESS CAMPUS |
| Manufacturer City | DUNFERMLINE, FIFE KY118GR |
| Manufacturer Country | UK |
| Manufacturer Postal | KY11 8GR |
| Manufacturer Phone | 1383843300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANORAMIC 200 OPHTHALMOSCOPE |
| Generic Name | AT TIME OF 510K, HLI (NEWER CODE MYC) |
| Product Code | HLI |
| Date Received | 2009-06-11 |
| Model Number | P200 |
| Catalog Number | A1021 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OPTOS PLC |
| Manufacturer Address | DUNFERMLINE, FIFE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-06-11 |