D
Patient 1
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.
MAUDE MDR 3519306
- MDR report key
- 3519306
- Report number
- 9680353-2013-00164
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-11-25
- Date received
- 2013-12-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MS KATHRYN CADORETTE
- Address
- 5960 HEISLEY ROAD MENTOR OH 44060 US
- Phone
- 440-440-4403
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RELIANCE 220/220L CART WASHER | WASHER | STERIS CANADA CORPORATION | FLH | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-12-13 | 0 |
Event Narratives#
N
Patient 1
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.