MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-16 for RELIANCE SYNERGY WASHER manufactured by Steris Canada Corporation.
[3072655]
The user facility reported that water was leaking from underneath the unit. The amount of water was approximately 6 gallons. The following day the user facility reported that water was leaking from the unit. No injuries, procedural delays/cancellations or property damage reported.
Patient Sequence No: 1, Text Type: D, B5
[10246890]
A steris service technician inspected the unit for the first reported event and found a small leak on the main hose and a leak to the spray arm. The technician replaced all the hoses on the recirculation system. The technician ran two test cycles and found the unit to be operating properly. The steris service technician inspected the unit the following day per the customer's report of continued leaking and could not verify where the reported water leak was coming from. He did find that the insulation on the main hose going to the spray arm to be wet, but no leak was observed. The technician verified that all hoses and clamps were secured. The technician ran two test cycles and confirmed the unit was operational; no further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2012-00086 |
| MDR Report Key | 2792858 |
| Report Source | 06 |
| Date Received | 2012-10-16 |
| Date of Report | 2012-10-16 |
| Date of Event | 2012-09-20 |
| Date Mfgr Received | 2012-09-20 |
| Date Added to Maude | 2013-01-29 |
| 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 SYNERGY WASHER |
| Generic Name | WASHER |
| Product Code | LDS |
| Date Received | 2012-10-16 |
| 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 | 2012-10-16 |