MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-26 for HARMONY IQ 3600 INTEGRATION SYSTEM manufactured by Vts Medical Systems.
[4798475]
The user facility reported that during a patient procedure, the monitor blanked out and continued to blink during the case. A replacement monitor was brought into the room and the procedure was completed successfully. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[12372433]
The investigation of this event is currently in process. A follow-up report will be submitted once additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[30057375]
A steris service specialist arrived at the facility, inspected the integration system and determined the issue was caused by the camera utilized at the time of the event. The technician made the necessary adjustments, tested the integration system and confirmed the unit was operating to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2014-00008 |
| MDR Report Key | 4122291 |
| Report Source | 05 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-04 |
| Date Mfgr Received | 2014-09-04 |
| Date Added to Maude | 2014-10-06 |
| 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 3600 INTEGRATION SYSTEM |
| Generic Name | INTEGRATION SYSTEM |
| Product Code | LMD |
| Date Received | 2014-09-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-09-26 |