MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for HARMONY IQ 3600 INTEGRATION SYSTEM manufactured by Vts Medical Systems.
[34916877]
A steris service technician inspected the integration system and found that the record button and vu capture page was stuck in the depressed position; the screen was unresponsive. The technician rebooted the integration system and the procedure was completed successfully. The technician was unable to duplicate the reported event. The procedure was minimally delayed due to the reported event. The integration system is under steris service contract and received routine preventive maintenance on (b)(6) 2015; no issues were noted.
Patient Sequence No: 1, Text Type: N, H10
[34916878]
The user facility reported that during a patient procedure the touch panel for their integration system froze. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2015-00008 |
| MDR Report Key | 5320996 |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-11-30 |
| Date Mfgr Received | 2015-11-30 |
| Date Added to Maude | 2015-12-22 |
| 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 | 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 3600 INTEGRATION SYSTEM |
| Generic Name | INTEGRATION SYSTEM |
| Product Code | KQM |
| Date Received | 2015-12-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VTS MEDICAL SYSTEMS |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-22 |