MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-22 for RELIANCE 120L CART WASHER manufactured by Steris Canada Corporation.
[15842201]
The user facility reported their reliance 120l cart washer had a steam leak. The reported steam leak caused an employee to experience eye discomfort. The employee sought medical treatment. No report of procedural delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
[16145095]
The employee subject of the reported event was on the decontamination side of the washer and had loaded the cart into the washer. The employee proceeded to clean other instruments when she reported steam was filling the room. The employee vacated the room and sought medical treatment for eye discomfort. The unit subject of the reported event is maintained by the user facility and the customer chose not to place a service request with steris. The technician was not permitted to inspect the unit, but was allowed to observe the customer as they ran several cycles on the unit. The observed cycles did not have any issues or alarms and were completed successfully. Steris attempted to follow up with the user facility about the current condition of the employee subject of the reported event, but the user facility did not provide any additional information regarding the employee. However, the user facility did confirm that the unit subject of the reported event has not experienced any additional issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2015-00032 |
| MDR Report Key | 4720048 |
| Report Source | 06 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-22 |
| Date of Event | 2015-03-25 |
| Date Mfgr Received | 2015-03-25 |
| Date Added to Maude | 2015-05-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE 120L CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2015-04-22 |
| 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 GIC8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-22 |