MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for INTEGRATED DIGITAL SURGICAL RACK manufactured by Black Diamond Video.
[138374309]
User facility personnel immediately powered down the integrated digital surgical rack. A steris service technician arrived onsite to inspect the unit and found that the isolation transformer had overloaded. Isolation transformers are used to protect equipment from electrical surges. The technician replaced the isolation transformer, tested the unit, confirmed it to be operating according to specification, and returned it to service. A 3-year complaint review indicates this to be an isolated event. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[138374310]
The user facility reported a burning odor and smoke emitting from their integrated digital surgical rack during a patient procedure. Report of staff nose and eye irritation. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008776287-2019-00001 |
| MDR Report Key | 8401729 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-03-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| 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 | 2019-03-07 |
| 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 | 2019-03-07 |