MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-03-29 for EAGLE EO MONITOR MP844903 manufactured by Steris Mexico, S. De R.l. De C.v..
[15212114]
The user facility reported that the eo monitor attached to the eo sterilizer was issuing intermittent eo alarms. After the steris technician performed maintenance on the eo disposer on (b)(6) 2012, the alarm on the eo monitor went off. When this occurred, the sterile processing department (spd) ) was evacuated per established facility procedures and the fire department called. A (b)(6) team responded and detected no eo gas, after which the spd department staff returned to work. No injuries were reported, no medical treatment was sought and no procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[15751868]
The steris technician inspected the eo monitor and found that port a was giving false alarms. The technician replaced a faulty battery and cpu board controlling port a, re-calibrated the eo monitor and ran a full sampling cycle on all ports which detected no eo. It is concluded that the alarms originating from port a of the eo monitor were false and no release of eo occurred. The false alarms were caused by a faulty battery and the cpu board controlling port a of the eo monitor; both were replaced. The eo sterilizer and eo monitor were tested successfully and placed back into service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2012-00020 |
| MDR Report Key | 2509965 |
| Report Source | 06 |
| Date Received | 2012-03-29 |
| Date of Report | 2012-03-29 |
| Date of Event | 2012-03-08 |
| Date Mfgr Received | 2012-03-08 |
| Date Added to Maude | 2012-03-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| 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 | 2012-03-29 |
| Model Number | MP844903 |
| 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 | 2012-03-29 |