D
Patient 1
THE USER FACILITY REPORTED THAT THEIR EO GAS STERILIZER ALARMED. NO INJURY WAS REPORTED.
MAUDE MDR 4571972
- MDR report key
- 4571972
- Report number
- 3005899764-2015-00014
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-02-04
- Date received
- 2015-03-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MS KATHRYN CADORETTE
- Address
- 5960 HEISLEY ROAD MENTOR OH 44060 US
- Phone
- 440-440-4403
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3017 EO GAS STERILIZER | STERILIZER | STERIS MEXICO, S. DE R.L. DE C.V. | FLF | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-03-05 | 0 |
Event Narratives#
N
Patient 1
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.