MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-07 for IDSS RGB CONVERTER manufactured by Black Diamond Video.
[62189450]
User facility personnel stated that the monitor was displaying a green scale instead of the grey scale. The grey scale is a black and white image and the green scale is a green and white image. The green and white image occurred during the reported event. A (b)(4) service technician arrived onsite to inspect the equipment. During the technician's inspection, he found that the rgb converter was not operating properly. The function of the rgb converter is to take an analog rgb video signal and convert it into a dvi signal that is compatible with the steris (b)(4) idss system. During the reported event, the rgb converter takes the video signal from the ge fluoroscope and converts it into the dvi signal. It is also configured to tell the idss system to treat the signal as a grey scale. The rgb converter is a steris (b)(4) product and is serviced and maintained by steris (b)(4). The investigation of this event is currently in process. A follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[62189451]
The user facility reported that during a patient procedure the image on the monitor turned from grey to green. User facility personnel continued to use the monitor as the image was still projected and the patient procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[74919354]
The idds product includes a high resolution surgical display. The user facility reported that the display's grey scale image changed to green scale during a patient procedure. The user facility successfully completed the procedure; no injuries or delays occurred as a result of the reported event. A service technician inspected the idds equipment and determined the rgb converter and power supply required replacement. The technician replaced the components, inspected and cleaned the equipment connections, and returned the idds to service. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008776287-2016-00001 |
| MDR Report Key | 6153000 |
| Date Received | 2016-12-07 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-11-07 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2016-12-07 |
| 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 | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | BLACK DIAMOND VIDEO |
| Manufacturer Street | 503 CANAL BLVD. |
| Manufacturer City | RICHMOND CA 94804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDSS RGB CONVERTER |
| Generic Name | RGB CONVERTER |
| Product Code | FWC |
| Date Received | 2016-12-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLACK DIAMOND VIDEO |
| Manufacturer Address | 503 CANAL BLVD. RICHMOND CA 94804 US 94804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-07 |