MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-21 for STERIS LA FIBER OPTIC ENABLED SYSTEM RL6185428101204 manufactured by Steris Corp.
[4182582]
Steris booms were put in at (b)(6) medical center one year ago. Throughout the year we had problems with the video monitors either going off and on during a case or having green horizontal lines and then going off for a short time. Steris was contacted multiple times and they provided engineers, observed cases, placed replacement equipment parts on site. The problems persist and the problems are becoming more frequent. The most recent cases occurred on (b)(6) 2013 monitor (b)(4), pt (b)(6) during a lap choley. The physician stopped while the monitor went off, then continued. On (b)(6) 2014 monitor (b)(4), with (b)(6) during an umbilical hernia repair. On (b)(6) 2014 monitor (b)(4) with pt (b)(6), the monitor blacked (b)(6) 2014 continued. The monitor blacked out during the procedure twice within 10 minutes. On (b)(6) 2014 monitor number (b)(4). On (b)(6) 2014 monitor (b)(4), in pt (b)(6) during a lap choley. The physicians wait till the monitor comes back on before continuing surgery. We currently have steris booms installed in operating rooms number 1, 2, 3, 4. The monitors were at first going out most of the time in operating room number 2 and steris thought they had fixed the problem. Now the incidents are occurring in all of the operating rooms with the steris booms. There is concern that the equipment is defective and will cause pt harm if not removed and replaced immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034696 |
| MDR Report Key | 3647138 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-02-11 |
| Date Added to Maude | 2014-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERIS LA FIBER OPTIC ENABLED SYSTEM |
| Generic Name | VIDEO MONITORS |
| Product Code | FWB |
| Date Received | 2014-02-21 |
| Model Number | RL6185428101204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORP |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 4401834 US 44018 34 |
| Brand Name | STERIS LA FIBER OPTIC ENABLED SYSTEM |
| Generic Name | VIDEO MONITORS |
| Product Code | FWB |
| Date Received | 2014-02-21 |
| Model Number | RS6185428101202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORP |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 4401834 US 44018 34 |
| Brand Name | STERIS LA FIBER OPTIC ENABLED SYSTEM |
| Generic Name | VIDEO MONITORS |
| Product Code | FWB |
| Date Received | 2014-02-21 |
| Model Number | RL6185428101203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORP |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 4401834 US 44018 34 |
| Brand Name | STERIS LA FIBER OPTIC ENABLED SYSTEM |
| Generic Name | VIDEO MONITORS |
| Product Code | FWB |
| Date Received | 2014-02-21 |
| Model Number | RL6185428101201 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORP |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 4401834 US 44018 34 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-21 |