MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-21 for HARMONY IQ INTEGRATION SYSTEM manufactured by Steris Corporation - Vts Medical Systems.
[58508683]
During the procedure the image displayed on the monitors 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 inspected the harmony iq integration system and found the video signal to the monitors required re-routing. The technician tested the system and confirmed it to be operating properly. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[58508684]
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 | 1000404456-2016-00009 |
| MDR Report Key | 6048106 |
| Date Received | 2016-10-21 |
| Date of Report | 2016-10-21 |
| Date of Event | 2016-09-23 |
| Date Mfgr Received | 2016-09-23 |
| Date Added to Maude | 2016-10-21 |
| 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 | STERIS CORPORATION - VTS MEDICAL SYSTEMS |
| Manufacturer Street | 40 MELVILLE PARK RD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| 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 | 2016-10-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - VTS MEDICAL SYSTEMS |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-21 |