MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-06 for HARMONY IQ 2800 INTEGRATION SYSTEM manufactured by Vts Medical Systems, Inc..
[15245239]
The user facility reported color distortion and static lines on their vividimage pro monitors. The facility contacted steris support in an attempt to resolve the reported issue; however, the color distortion and static lines remained. A procedural delay was reported due to the event.
Patient Sequence No: 1, Text Type: D, B5
[15767059]
Investigation of this event is currently in process. A follow up report will be submitted when additional info becomes available.
Patient Sequence No: 1, Text Type: N, H10
[30057157]
A steris service specialist arrived at the facility, inspected and tested the integration system and was able to duplicate the reported issue. The technician performed the necessary repairs including replacement of the vividimage pro monitors, tested the system and placed it back into service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2015-00002 |
| MDR Report Key | 4501322 |
| Report Source | 06 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-02-06 |
| Date of Event | 2015-01-07 |
| Date Mfgr Received | 2015-01-07 |
| Date Added to Maude | 2015-03-11 |
| 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, INC. |
| 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 | LMD |
| Date Received | 2015-02-06 |
| 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, INC. |
| Manufacturer Address | 40 MELVILLE PARK RD. MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-06 |