MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for HARMONY IQ 2800 INTEGRATION SYSTEM manufactured by Vts Medical Systems.
[39133929]
A steris service technician inspected the integration system and found that the touch panel was not responding. The touch panel present during the time of the reported event was a third party touch panel. The harmony iq 2800 integration system has usb ports which allow for the user to enable use of the integration system should the touch panel not operate properly. Although the user facility reported an isssue with their touch panel, the harmony iq 2800 integration was still active and able to be utilized via other manual override methods. The technician replaced the touch panel subject of the reported event with a steris touch panel, tested the system and confirmed it to be operational. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[39133930]
The user facility reported that their touch panel for their integration system was not operating properly. No report of injury however, procedural delays were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2016-00001 |
| MDR Report Key | 5447157 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-01-22 |
| Date Mfgr Received | 2016-01-22 |
| Date Added to Maude | 2016-02-19 |
| 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 2800 INTEGRATION SYSTEM |
| Generic Name | INTEGRATION SYSTEM |
| Product Code | KQM |
| Date Received | 2016-02-19 |
| 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 | 2016-02-19 |