MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-23 for RELIANCE 120 CART WASHER manufactured by Steris Canada Corporation.
[19319548]
A steris service technician arrived at the facility and found the recirculation pump head clamps had broken off. The technician rebuilt the recirculation pump head with a new cover, gasket and clamps. The unit was tested, confirmed to be operating to specification and was returned to service. The unit was installed in january 2004 and is currently under steris service contract. The last pm was performed on (b)(4) 2013 at which time the unit was confirmed to be operating to specification.
Patient Sequence No: 1, Text Type: N, H10
[19482168]
The user facility reported their unit was leaking water. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2013-00140 |
| MDR Report Key | 3425577 |
| Report Source | 06 |
| Date Received | 2013-10-23 |
| Date of Report | 2013-10-23 |
| Date of Event | 2013-09-24 |
| Date Mfgr Received | 2013-09-24 |
| Date Added to Maude | 2014-01-24 |
| 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 | RELIANCE 120 CART WASHER |
| Generic Name | WASHER |
| Product Code | LDS |
| Date Received | 2013-10-23 |
| 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 | 2013-10-23 |