MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for INTEGRATED DIGITAL SURGICAL RACK manufactured by Black Diamond Video.
[110734705]
Following the reported event, the integrated digital rack was removed from service. A steris service technician inspected the digital surgical rack and identified that the amplifier, a component of the integrated digital surgical rack, shorted causing the reported event to occur. The technician replaced the amplifier, tested the integrated digital surgical rack, and found it to be operating properly. The integrated digital rack was returned to service. The unit was installed at the customer's location in 2015 and no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[110734706]
The user facility reported a burning odor emitting from their integrated digital surgical rack. The burning odor was detected after all cases were completed for the day; no report of injury, procedure delay, or cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008776287-2018-00002 |
| MDR Report Key | 7579172 |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-05-08 |
| Date Added to Maude | 2018-06-07 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| 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 | 0 |
| Brand Name | INTEGRATED DIGITAL SURGICAL RACK |
| Generic Name | INTEGRATED DIGITAL SURGICAL RACK |
| Product Code | FWC |
| Date Received | 2018-06-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-06-07 |