MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-11 for HARMONY IQ 3600 * manufactured by Steris Corporation.
[15355915]
Steris control panel not functional for the past 2+ months. Volume jumping to 10, camera's not turning on, screens not staying on the correct setting. Unable to turn on monitors from the wall, lighting not reacting to mouse and mouse blinking. Monitors shutting off mid case without prompting. Called rep and left message, no response. Left 2nd message. Spoke with hospital it support and explained the problem. They stated they would have someone come out that afternoon. No changes in status of functionality, control panel still having identical problems as before. Called steris 800 number for support. They stated they will coordinate a dispatch to repair the control panel. ======================manufacturer response for steris control panel, harmony iq (per site reporter). ======================had to contact steris technical support several times before a field tech was scheduled to come out and make repairs to the system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4847075 |
| MDR Report Key | 4847075 |
| Date Received | 2015-05-11 |
| Date of Report | 2015-05-11 |
| Date of Event | 2015-04-24 |
| Report Date | 2015-05-11 |
| Date Reported to FDA | 2015-05-11 |
| Date Reported to Mfgr | 2015-06-16 |
| Date Added to Maude | 2015-06-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARMONY IQ |
| Generic Name | GENERAL SURGICAL CONTROL |
| Product Code | LMD |
| Date Received | 2015-05-11 |
| Model Number | 3600 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY ROAD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-11 |