MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-08 for 1227 CART WASHER manufactured by Steris Canada Corporation.
[4787618]
The user facility reported that a cycle aborted with a message of "alarm #44-unload door open during cycle". The employee opened the unload door and vapor released subsequently setting off the sprinkler system. No fire alarms were triggered and the fire department was not dispatched. No evacuations were reported. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[12398156]
A steris service technician arrived onsite and found the unload door to be open and the cart washer to be turned off via the emergency stop switch on the unload side of the washer. The technician ran several cycles and could not duplicate the reported event. The technician replaced the unload door switch, ran test cycles and confirmed the washer to be operational. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2014-00083 |
| MDR Report Key | 4152736 |
| Report Source | 06 |
| Date Received | 2014-10-08 |
| Date of Report | 2014-10-08 |
| Date of Event | 2014-09-09 |
| Date Mfgr Received | 2014-09-09 |
| Date Added to Maude | 2014-10-20 |
| 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 | 1227 CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2014-10-08 |
| 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 | 2014-10-08 |