MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-05 for 3017 EO GAS STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[21727342]
The user facility reported that their eo gas sterilizer alarmed. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[22022596]
A steris service technician arrived onsite and put the sterilizer in service mode to pull any remaining eo gas in the chamber. Before the technician's arrival the gas was contained in the sterilizer and the sterilizer operated properly to pull a vacuum after a cycle alarm. The technician opened the sterilizer door and found the gas canister needle still in the canister. When the technician removed the canister from the sterilizer the eo monitor located behind the sterilizer alarmed due to proximity of the canister to the alarm. Due to the alarm, the room was evacuated. The technician stated that a valve was not functioning properly causing the needle to puncture the gas canister out of sequence subsequently causing gas to release before the sterilization phase. The technician repaired the unit, ran a test cycle and confirmed it to be operational. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2015-00014 |
| MDR Report Key | 4571972 |
| Report Source | 06 |
| Date Received | 2015-03-05 |
| Date of Report | 2015-03-05 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-04 |
| Date Added to Maude | 2015-04-06 |
| 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 | 2015-03-05 |
| 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 | 2015-03-05 |