MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-04 for 120L CART WASHER manufactured by Steris Canada Corporation.
[3699044]
The user facility reported their unit was leaking water near electrical wires. The leak was approximated to be one gallon of water. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[10921906]
A steris service technician arrived at the facility and found the copper inlet water pipe to the water temperature booster tank leaking water. The leak caused water to contact the electrical wires to the inlet solenoid valves. The technician replaced the copper piping and cleaned the water level switches. The unit was installed in november of 1997 and has not been under a steris service contract since 2012. The replacement of the copper piping is attributed to the age of the component.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2013-00117 |
| MDR Report Key | 3325517 |
| Report Source | 06 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-09-04 |
| Date of Event | 2013-08-05 |
| Date Mfgr Received | 2013-08-05 |
| Date Added to Maude | 2013-12-03 |
| 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 | 120L CART WASHER |
| Generic Name | CART WASHER |
| Product Code | FLH |
| Date Received | 2013-09-04 |
| 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 | 2013-09-04 |