MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-31 for 120 CART WASHER manufactured by Steris Canada Corporation.
[5264357]
The user facility reported that an employee heard a fire alarm, checked the alarm panel and verified it was coming from the second floor decontamination room. The employee entered the room and observed smoke emitting from the cart washer and the sprinkler system going off. The employee turned off the sprinkler system, heard a whistling sound and observed bowing of the washer on one side. The employee turned off the steam and the noise stopped. The fire department was dispatched however, no evacuations were reported. No injuries were reported but procedures were rescheduled for the following day.
Patient Sequence No: 1, Text Type: D, B5
[12728657]
A steris service technician inspected the washer and found that the steam valve had stuck in the open position allowing the hot water tank to overheat. The technician repaired the washer, ran a test cycle and confirmed the washer to be operational. No additional issues have been reported. The technician stated that the sprinkler system was located above the washer during the time of the reported event and has since been relocated. The washer is serviced and maintained by the user facility's biomedical department.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2014-00098 |
| MDR Report Key | 4374631 |
| Report Source | 06 |
| Date Received | 2014-12-31 |
| Date of Report | 2014-12-31 |
| Date of Event | 2014-12-03 |
| Date Mfgr Received | 2014-12-03 |
| Date Added to Maude | 2015-01-16 |
| 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 | 120 CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2014-12-31 |
| 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 | 2014-12-31 |