D
Patient 1
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR RELIANCE SYNERGY WASHER AND OUT ONTO THE FLOOR AND DOWN THE STAIRS TO THE FIRST FLOOR. NO INJURIES, PROCEDURAL DELAYS/CANCELLATIONS OR PROPERTY DAMAGE WERE REPORTED.
MAUDE MDR 2760686
- MDR report key
- 2760686
- Report number
- 9680353-2012-00075
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-08-30
- Date received
- 2012-09-26
- 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 LINDSEY MCGOWAN
- 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 SYNERGY WASHER | WASHER | STERIS CANADA CORPORATION | LDS | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-09-26 | 0 |
Event Narratives#
N
Patient 1
A STERIS SERVICE TECHNICIAN INSPECTED THE WASHER AND FOUND A LOOSE HOSE ON THE PIPE TO THE BOTTOM SPRAY ARM. THE TECHNICIAN REPAIRED THE HOSE AND RETURNED THE UNIT TO SERVICE.