MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-09 for 120L CART WASHER manufactured by Steris Canada Corporation.
[16869368]
The user facility reported that hot water remained in the bottom of the cart washer chamber after the end of a cycle run. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[17090821]
A steris service technician arrived at the facility and found the hot water tank's solenoid valve was worn and required replacement. The technician replaced the solenoid valve, ran a test cycle and returned the unit to service. The unit was installed in july of 2007 and is currently under a steris service contract. The last pm was performed on july 12, 2013 at which time the unit was confirmed to be operating to specification. No further issues reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2013-00134 |
| MDR Report Key | 3397348 |
| Report Source | 06 |
| Date Received | 2013-10-09 |
| Date of Report | 2013-10-09 |
| Date of Event | 2013-09-12 |
| Date Mfgr Received | 2013-09-12 |
| Date Added to Maude | 2014-01-10 |
| 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 | WASHER |
| Product Code | LDS |
| Date Received | 2013-10-09 |
| 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 | 2013-10-09 |