MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-08 for HARMONY IQ 2400 INTEGRATION SYSTEM manufactured by Vts Medical Systems.
[42956600]
A steris service technician inspected the integration system and found that the power connector to the internal hard drive had shorted. The technician replaced the integration system due to the damage. The integration system was placed into service and no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[42956601]
The user facility reported that smoke was emitting from their integration system. No report of injury however, a procedural delay was reported due to the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2016-00003 |
| MDR Report Key | 5563976 |
| Date Received | 2016-04-08 |
| Date of Report | 2016-04-08 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-03-11 |
| Date Added to Maude | 2016-04-08 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | HARMONY IQ 2400 INTEGRATION SYSTEM |
| Generic Name | INTEGRATION SYSTEM |
| Product Code | KQM |
| Date Received | 2016-04-08 |
| 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 | 2016-04-08 |