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.
[100917658]
A steris service technician arrived onsite following the reported event. The technician inspected the unit and found the air inlet check valve was stuck in the closed position preventing proper draining of the system 1e processor. To resolve the issue, the technician adjusted the air inlet check valve, ran a test cycle, and confirmed the unit to be operating according to specifications. The failure of the check valve may be attributed to low usage of the system 1e processor, and failure to run a daily diagnostic cycle as stated in the system 1e operator manual. The operator manual (8-7) states, "steris recommends running a diagnostic cycle once every 24 hours". A review of the user facility's system 1e cycle records indicates the customer ran a low volume of processing cycles, 58 total, over an approximate one year time-frame. The technician informed the facility's biomed technician of the importance of completing a daily diagnostic cycle, as recommended in the system 1e operator manual. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[100917659]
The user facility reported water leaking from their system 1e processor. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2018-00017 |
| MDR Report Key | 7290617 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-01-24 |
| 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 |