MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-03 for 120 CART WASHER manufactured by Steris Canada Corporation.
[17994743]
The user facility reported that their washer was leaking hot water and steam. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[18393321]
The hot water leak was contained within the unit's chamber and did not exit the unit. The steam leak was external, however, water did not accumulate on the floor. Two steris field service technicians inspected the washer and identified that the washer required several repairs including replacement of the heat exchanger and the steam valve.
Patient Sequence No: 1, Text Type: N, H10
[25235744]
The heat exchanger has been replaced. The unit was tested and returned to service. No additional issues were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2014-00082 |
| MDR Report Key | 4140611 |
| Report Source | 06 |
| Date Received | 2014-10-03 |
| Date of Report | 2014-10-03 |
| Date of Event | 2014-09-03 |
| Date Mfgr Received | 2014-09-03 |
| Date Added to Maude | 2014-10-16 |
| 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 | 2014-10-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-10-03 |