MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-15 for RELIANCE 220 CART WASHER manufactured by Steris Canada Corporation.
[19986883]
The user facility reported their reliance 220 cart washer was emitting steam from around the doors during a cycle. The fire alarm was triggered due to the reported event, but no evacuations occurred. No report of injury or procedural delay or cancellation. The fire department was not dispatched to the user facility.
Patient Sequence No: 1, Text Type: D, B5
[20430657]
A steris field service technician arrived onsite, inspected the unit, and identified the drying fan's belts required replacement. Due to the damaged belt on the drying fan, the fan was not able to clear the steam and condense it from within the cart washer effectively and thus caused the reported event. The technician replaced the drying fan belt. He tested the unit, ensured the steam cleared properly, and confirmed it to be operating according to specification. This unit is not under steris contract agreement for maintenance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2015-00030 |
| MDR Report Key | 4694944 |
| Report Source | 06 |
| Date Received | 2015-04-15 |
| Date of Report | 2015-04-15 |
| Date of Event | 2015-03-17 |
| Date Mfgr Received | 2015-03-17 |
| Date Added to Maude | 2015-05-15 |
| 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 220 CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2015-04-15 |
| 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 | 2015-04-15 |