MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-04-01 for EAGLE 3017 100% ETO STERILIZER 1301043 manufactured by Steris Mexico, S.de R.l. De C.v..
[1080263]
While opening the door of an eagle ethylene oxide sterilizer, the operator reported that a burst of hot air came out and struck her face. The employee inhaled the air, which irritated her eyes and throat. The employee went to the emergency room for treatment and was hospitalized for observation and released. No further information has been reported. The employee stated this event occurred when the sterilizer was opened for the first time after sitting idle over the weekend.
Patient Sequence No: 1, Text Type: D, B5
[1898100]
Steris contacted the user facility for additional information on the injured employee, however no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[8255094]
A steris technician inspected the sterilizer and discovered an oily substance in the sterilizer chamber and a strong pungent odor. Each of the 4 ethylene oxide sterilizers at this site were found to have the oily substance and accompanying odor. The odor detected may have originated from the oily substance sitting in the machines as the machines remain at 130 degrees f when idle. However, the origin of the oily substance is unknown. The hospital's facilities department checked the compressor for oil leaks, but the compressor in this device does not use oil. The bronze sintered elements located in the device's air dryers were replaced and checked for oil, but no oil was found. The steris technician shut down the unit, which was taken out of service. The facility continues to use its three other sterilizers units. The investigation into the source of the oily substance and odor is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2009-00003 |
| MDR Report Key | 1353648 |
| Report Source | 05,06,07 |
| Date Received | 2009-04-01 |
| Date of Report | 2009-04-01 |
| Date of Event | 2009-03-02 |
| Device Manufacturer Date | 2002-10-07 |
| Date Added to Maude | 2009-04-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MONTSERRAT POSADA |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, NUEVO LEON 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal | 67190 |
| Manufacturer Phone | 818008 832 |
| 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 3017 100% ETO STERILIZER |
| Generic Name | 3017 ETO STERILIZER |
| Product Code | FLF |
| Date Received | 2009-04-01 |
| Model Number | 1301043 |
| Catalog Number | 1301043 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Age | DA |
| 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. Hospitalization | 2009-04-01 |