MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for SYSTEM 1E PROCESSOR manufactured by Steris Canada Corporation.
[146075732]
A steris service technician arrived onsite to inspect the system 1e processor and found that a cable had shorted subsequently causing a loss of power to the control board. The loss of power to the control board subsequently caused the unit to not be able to deflate the seal to allow the lid to open. The technician replaced the cable, tested the unit, confirmed it to be operating according to specification, and returned it to service. The unit was installed in 2011 making it approximately 8 years old. A 3-year complaint review indicates this to be an isolated event. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[146075733]
The user facility reported that their system 1e processor lid would not open. The facility reported procedure cancellations as scopes were stuck inside the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2019-00017 |
| MDR Report Key | 8634155 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-05-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MED |
| Date Received | 2019-05-22 |
| 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 | 2019-05-22 |