MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-17 for HARMONY IQ 2800 INTEGRATION SYSTEM manufactured by Vts Medical Systems.
[22385440]
A steris account manager interviewed multiple user facility clinical engineering and biomedical personnel and identified that the harmony iq integration system was operating properly with the exception of an intermittent issue with the video quality from a non-steris camera to a monitor. The steris account manager and the camera manufacturer's account manager reviewed the integration system, monitor, and camera and identified that the monitor settings were incorrect. These settings can be adjusted by user facility personnel. The account managers reset the monitoring settings and advised the hospital biomedical staff of the proper settings. A steris service technician also inspected the harmony iq integration system, performed a full functional test of the unit, and found the system to be operating according to specification. No additional issues have been reported. The harmony iq integration system was installed by steris on (b)(6) 2013. It is not under steris service contract for maintenance.
Patient Sequence No: 1, Text Type: N, H10
[22385441]
Reference user facility medwatch (b)(4). The user facility reported that the control panel on their harmony iq 2800 integration system was not operating properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2015-00006 |
| MDR Report Key | 4922914 |
| Report Source | 06 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-17 |
| Date of Event | 2015-04-24 |
| Date Mfgr Received | 2015-06-18 |
| Date Added to Maude | 2015-08-06 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 3 |
| Brand Name | HARMONY IQ 2800 INTEGRATION SYSTEM |
| Generic Name | INTEGRATION SYSTEM |
| Product Code | KQM |
| Date Received | 2015-07-17 |
| 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 | 1. Other | 2015-07-17 |