MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-26 for RELIANCE 777 WASHER manufactured by Steris Canada Corporation.
[17566399]
The user facility reported that their reliance 777 washer was leaking water out onto the floor in the room where the washer is located and into the floor below. No injuries to hospital staff or patient. Procedural delays and property damage were reported.
Patient Sequence No: 1, Text Type: D, B5
[17645642]
A steris service technician inspected the unit and found that there was a leak from the main pump in the wash section and also noted leaks from other places on the unit. The technician repaired the unit, ran test cycles and confirmed it was operational. The user facility has purchased a new steris synergy mc washer which is scheduled to be installed in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2012-00088 |
| MDR Report Key | 2806612 |
| Report Source | 06 |
| Date Received | 2012-10-26 |
| Date of Report | 2012-10-26 |
| Date of Event | 2012-09-29 |
| Date Mfgr Received | 2012-09-29 |
| Date Added to Maude | 2013-02-05 |
| 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 LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| 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 777 WASHER |
| Generic Name | WASHER/DISINFECTOR |
| Product Code | LDS |
| Date Received | 2012-10-26 |
| Operator | OTHER HEALTH CARE 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 | 2012-10-26 |