D
Patient 1
THE USER FACILITY REPORTED THE WASHER WAS LEAKING WATER. THE WATER SPREAD INTO THE OPERATOR'S WORKING AREA. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.
MAUDE MDR 3601638
- MDR report key
- 3601638
- Report number
- 9680353-2014-00014
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-01-10
- Date received
- 2014-01-31
- 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 CART WASHER | WASHER | STERIS CANADA CORPORATION | FLH | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-01-31 | 0 |
Event Narratives#
N
Patient 1
A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE WASHER AND FOUND THE GASKET HOLDER WAS NOT PROPERLY ATTACHED TO THE DOOR CAUSING THE WATER LEAK. THE TECHNICIAN REATTACHED THE DOOR SEALS, COMPLETED A TEST CYCLE AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION. THE GASKET HOLDER DAMAGE WAS CAUSED BY IMPROPER LOADING OF THE CART INTO THE WASHER. WHILE ONSITE, THE TECHNICIAN INSTRUCTED THE FACILITY ON THE PROPER WAY OF LOADING CARTS INTO THE WASHER. THE UNIT WAS INSTALLED IN 1999 AND HAS NOT BEEN UNDER A STERIS SERVICE CONTRACT SINCE 2007.