MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-09 for HARMONY IQ 3600 INTEGRATION SYSTEM manufactured by Vts Medical Systems.
[5366593]
The user facility reported during a patient procedure, one of their in-field monitors went out. No injuries or procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[12744414]
A steris field service technician arrived onsite, inspected the unit, and worked with a member of the ori team to test the facility wiring and integration system. The technician identified an arc within the unit. A short was occurring between the red power cable for the monitor and the grounding spring cable that is routed in the mesh cover as a part of the wiring bundle for the boom. When the cable came in contact with the spindle, the system experienced an electrical short. The technician replaced the cpu stack, the monitor cable, and the serial board. The two monitors will also be replaced to ensure the system will be operating according to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2015-00001 |
| MDR Report Key | 4404300 |
| Report Source | 06 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-01-09 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2014-12-11 |
| Date Added to Maude | 2015-01-30 |
| 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 | 2015-01-09 |
| 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 | 2015-01-09 |