MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-26 for RELIANCE 1227 CART WASHER manufactured by Steris Canada Corporation.
[18853541]
The user facility reported a gust of hot air escaped the washer when the door was opened which initiated the sprinkler system. No injuries were reported. No procedural delays or cancellations occurred.
Patient Sequence No: 1, Text Type: D, B5
[19293748]
A steris service technician inspected the unit and found the low speed pressure switch not working properly. The technician replaced the low pressure switch, ran a test cycle and confirmed the unit operational. A hospital employee used the service security code to override the locking mechanism to open the washer door, which caused the reported steam to infiltrate the room. The 1227 cart washer operator manual does not instruct use of the service security code; the service security code is to be used by steris technicians only. The hospital staff has been has been counseled that they are not, under any circumstances, to use the service security code to override a cycle or alarm that the unit may be experiencing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2013-00129 |
| MDR Report Key | 3371559 |
| Report Source | 06 |
| Date Received | 2013-09-26 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-08-28 |
| Date Mfgr Received | 2013-08-28 |
| Date Added to Maude | 2014-01-03 |
| 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 1227 CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2013-09-26 |
| 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 | 2013-09-26 |