MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for SYSTEM 1E PROCESSOR manufactured by Steris Canada Corporation.
[100920546]
No report of procedure delay or cancellation. Following the reported event, a steris service technician arrived onsite to inspect the unit. The technician found the unit to be operating according to specification; no repairs were required. While on-site, the technician identified that the user facility's work room where the system 1e processor is located has inadequate air circulation. A steris account manger spoke to the facility's personnel regarding ventilation options to the work room where the system 1e is located. The user facility will work towards adding ventilation to the work room. Section 3-3 of the system 1e operator manual state "the sterilant concentrate should be used in a well ventilated room. Conformance to aami st58 is recommended". The system 1e operator manual (2-2) states, "warning: to avoid accumulated concentration of peracetic acid vapor, use s40 sterilant concentrate in a well ventilated room or area. " no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[100920547]
The user facility reported that their system 1e processor was emitting an odor. An employee experienced a mild headache as a result. No medical treatment was sought or administered and the employee continued working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2018-00016 |
| MDR Report Key | 7290601 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-01-23 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-02-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC 8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYSTEM 1E PROCESSOR |
| Generic Name | PROCESSOR |
| Product Code | NZA |
| Date Received | 2018-02-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA CORPORATION |
| Manufacturer Address | 490 ARMAND-PARIS QUEBEC, QUEBEC GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-22 |