MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for HARMONY IQ INTEGRATION SYSTEM manufactured by Black Diamond Video.
[117450715]
During the procedure the image displayed on the monitor in the surgical room was not available. The harmony iq integration system required a restart subsequently causing a delay in the procedure. After the image was restored the patient procedure was completed successfully. No report of injury. A steris service technician arrived onsite to inspect the harmony iq integration system and found that the system's hard drive required replacement. The technician replaced the hard drive, tested the system, and confirmed it to be operating properly. No additional issues have been noted since replacement of the hard drive.
Patient Sequence No: 1, Text Type: N, H10
[117450716]
The user facility reported that during a patient procedure their harmony iq integration system did not operate properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008776287-2018-00004 |
| MDR Report Key | 7789511 |
| Date Received | 2018-08-16 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-07-17 |
| Date Added to Maude | 2018-08-16 |
| 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 | HARMONY IQ INTEGRATION SYSTEM |
| Generic Name | INTEGRATION SYSTEM |
| Product Code | KQM |
| Date Received | 2018-08-16 |
| 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 | 2018-08-16 |