MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-31 for HARMONY IQ SYSTEM manufactured by Vts Medical Systems.
[54401229]
A steris service technician inspected the system and found that the cause of the reported event is due to polling of the harmony iq system to the monitor. Polling is when the harmony iq system "pings" the monitor to obtain a status. 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
[54401230]
The user facility reported that during a patient procedure their monitor powered down. No injuries or procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[63647123]
The steris service technician made proper repairs to the harmony iq system by removing the polling and confirmed the system to be operating properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2016-00006 |
| MDR Report Key | 5919170 |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-02 |
| Date Added to Maude | 2016-08-31 |
| 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 | 3 |
| Brand Name | HARMONY IQ SYSTEM |
| Generic Name | CUSTOMIZED RACK |
| Product Code | KQM |
| Date Received | 2016-08-31 |
| 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 | 2016-08-31 |