MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for SYSTEM 1E PROCESSOR manufactured by Steris Canada Corporation.
[133326890]
A steris service technician arrived onsite to inspect the processor and found the filter housing assembly for the water filtration system was cracked allowing water to leak out onto the floor. The user facility replaced the filter housing. The technician tested the unit, confirmed it to be operating according to specification, and returned it to service. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[133326891]
The user facility reported that their system 1e processor was leaking water onto the floor. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2019-00003 |
| MDR Report Key | 8254717 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-12-27 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2019-01-16 |
| 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 | SYSTEM 1E PROCESSOR |
| Product Code | MED |
| Date Received | 2019-01-16 |
| 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 | 2019-01-16 |