MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-13 for RELIANCE 220/220L CART WASHER manufactured by Steris Canada Corporation.
[3965709]
The user facility reported their unit was leaking steam. The fire alarm and sprinkler systems were not activated and the facility did not require evacuation. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[11324676]
A steris service technician arrived at the facility, inspected the washer and found the hot water tank was overheating. The technician also observed the solenoid valve below the unit's hot water tank was leaking water. The technician replaced the temperature control thermostat which was causing the tank to overheat and replaced the solenoid valve. The thermostat was properly adjusted, a test cycle was completed and the unit was returned to operation. The following day, the user facility reported the unit did not have power. The steris service technician returned to the facility and found the hot water fill valve flare fitting was leaking water onto the unit's thermostat, causing a short of the thermostat and a constantly energized steam valve. The energized steam valve severely overheated the unit's hot water tank and caused water to boil over the tank and down onto the unit's electrical box causing the unit to shut down. The technician replaced the damaged thermostat and solenoid valve, tightened the flare fitting, dried the electrical box, ran a test cycle and returned the unit to service. The washer was installed in june of 1998 and is currently under a steris service contract. The last preventive maintenance was performed on october 23, 2013 at which time the unit was confirmed to be operating to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2013-00164 |
| MDR Report Key | 3519306 |
| Report Source | 06 |
| Date Received | 2013-12-13 |
| Date of Report | 2013-12-13 |
| Date of Event | 2013-11-25 |
| Date Mfgr Received | 2013-11-25 |
| Date Added to Maude | 2014-03-17 |
| 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 220/220L CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2013-12-13 |
| 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 | 2013-12-13 |