MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-08 for EAGLE EO MONITOR manufactured by Steris Mexico, S. De R.l. De C.v..
[21108159]
The user facility reported that their eagle eo monitor was alarming? High leak rate of 9. 12?. The surgical department was evacuated and emergency services were contacted. No injuries to hospital staff or patients were reported. No procedural delays or cancellations occurred.
Patient Sequence No: 1, Text Type: D, B5
[21158883]
A steris service technician arrived at the facility to inspect the unit. The technician confirmed that no eto sterilizers were running on the day of the reported event. The monitor was found to be operating to specification. Emergency services were contacted by the user facility. The eo alarm turned off before they arrived. The monitor alarmed for one full cycle only. The technician confirmed the alarm initiated by a non-eo odor as the monitor is located in area with multiple devices and frequent traffic.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2013-00067 |
| MDR Report Key | 3211373 |
| Report Source | 06 |
| Date Received | 2013-07-08 |
| Date of Report | 2013-07-08 |
| Date of Event | 2013-06-09 |
| Date Mfgr Received | 2013-06-09 |
| Date Added to Maude | 2013-07-09 |
| 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 | 0 |
| Event Location | 0 |
| 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 | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, NUEVO LEON 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 67190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAGLE EO MONITOR |
| Generic Name | STERILIZER MONITOR |
| Product Code | FLF |
| Date Received | 2013-07-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Address | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE GUADALUPE, NUEVO LEON 67190 MX 67190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-08 |