MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-14 for RELIANCE SYNERGY WASHER manufactured by Steris Canada Corporation.
[10526025]
The hospital's insurance company has refused release of the synergy washer (both entirely or parts) subject of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[19382386]
Investigation in process.
Patient Sequence No: 1, Text Type: N, H10
[19419399]
The user facility reported their reliance synergy washer/disinfector "caught on fire". The staff started to smell acrid fumes while the synergy was running in the drying phase of an instrument cycle. The staff informed the hospital engineer and shortly after noticed flames coming from the top of the synergy washer, triggering the sprinkler system and fire alarm to go off. The hospital engineer actuated the emergency stop on the unit and shortly after fire department personnel arrived onsite.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2012-00123 |
| MDR Report Key | 2873922 |
| Report Source | 06 |
| Date Received | 2012-12-14 |
| Date of Report | 2012-12-14 |
| Date of Event | 2012-11-19 |
| Date Mfgr Received | 2012-11-19 |
| Date Added to Maude | 2013-03-20 |
| 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 | 2012-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-12-14 |