MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-12 for HARMONY IQ 3600 INTEGRATION SYSTEM manufactured by Vts Medical Systems, Llc.
[4457695]
The user facility reported that vitals are not displaying on touch panel.
Patient Sequence No: 1, Text Type: D, B5
[11971713]
The investigation of this event is currently in process. A follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[30057200]
A steris service technician was in the room at the time of the event. The technician inspected the unit and determined the vga cord required replacement due to a bent pin. The technician replaced the cord and restarted the machine. The technician confirmed the unit was operating to specification. No additional issues have been reported by the facility pertaining to this unit. The unit was installed in november 2013, and is currently under warranty.
Patient Sequence No: 1, Text Type: N, H10
[30057201]
No injuries, or procedure delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2014-00002 |
| MDR Report Key | 3869713 |
| Report Source | 05 |
| Date Received | 2014-06-12 |
| Date of Report | 2014-06-12 |
| Date of Event | 2014-05-13 |
| Date Mfgr Received | 2014-05-13 |
| Date Added to Maude | 2014-07-10 |
| 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 ROAD |
| Manufacturer City | MELVILLE NY 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARMONY IQ 3600 INTEGRATION SYSTEM |
| Generic Name | HARMONY IQ |
| Product Code | LMD |
| Date Received | 2014-06-12 |
| 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, LLC |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-12 |