MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-10 for HARMONY IQ * manufactured by Steris Corporation.
[17618841]
Initial issue with steris harmony integrated or system was expressed. The bovie machine was creating interference with our in light camera feed during open cases causing the monitoring to fail. This issue is currently not resolved by steris. It was reported several months later that steris monitors began flickering in the midst of a laparoscopic case. All monitors then ceased to show and image while the surgeon was in the patients abdominal cavity, unable to resolve issue and old stand-alone brought in to complete the case. The monitors kept blacking out during a laparoscopic surgery, again was unable to resolve the monitor issue. During laparoscopic cases the visual on monitor (non-hd) from the endoscope is observed; however, the integrity of the video on the steris harmony surgical system hd integrated monitors is compromised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4023151 |
| MDR Report Key | 4023151 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-03-05 |
| Date of Event | 2014-02-12 |
| Report Date | 2014-03-05 |
| Date Reported to FDA | 2014-03-10 |
| Date Reported to Mfgr | 2014-08-20 |
| Date Added to Maude | 2014-08-20 |
| 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 | MONITOR |
| Product Code | LMD |
| Date Received | 2014-03-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 10 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-10 |