MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-10 for 3017 EO GAS STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[3653061]
The user facility reported their eo monitor system activated, alerting the department of a potential eo gas leak. The hospital employees evacuated the department where the eo monitor and sterilizer were located. No patients required evacuation. No procedural delays/cancellations or injuries were reported with the event.
Patient Sequence No: 1, Text Type: D, B5
[10968960]
A steris service technician arrived at the facility and was informed that the facility's eo monitor had activated approximately 10 minutes after the sterilizer went into exhaust. The monitor alarmed for approximately 20 minutes, after which time hospital employees went back into the department. The eo monitor is not manufactured or maintained by steris. The technician evaluated the sterilizer exhaust line, check valve and moisture trap as these are the potential sources for an eo gas leak. The technician did not identify any signs of leaking from the sterilizer. After discussion with the customer, the exhaust line, check valve and moisture trap were proactively replaced due to the age of the components, approximately 18 years old. The eo sterilizer was installed in 1996 and is not currently under a steris service contract. The unit is maintained by the facility's biomed department. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2013-00068 |
| MDR Report Key | 3217498 |
| Report Source | 06 |
| Date Received | 2013-07-10 |
| Date of Report | 2013-07-10 |
| Date of Event | 2013-06-11 |
| Date Mfgr Received | 2013-06-11 |
| Date Added to Maude | 2013-10-02 |
| 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 | 3017 EO GAS STERILIZER |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2013-07-10 |
| 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 | 2013-07-10 |