MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-05 for CAVIWAVE PRO ULTRASONIC CLEANING SYSTEM manufactured by Steris Corporation - Distribution Center.
[89936294]
The user facility initially reported that a burning smell and small fire were emitting from the caviwave cleaner. No instruments were present during the time of the reported event. A steris service technician arrived onsite to inspect the unit. Contrary to the reported event, the technician found no evidence of fire damage inside the unit. The technician inspected the unit's electrical components and wiring and found no evidence of smoke or fire. The technician further inspected the unit's generator and found no blown fuses. Prior to the steris service technician's arrival, the user facility's biomedical technician inspected the unit and found that one of the contactors required replacement. The steris technician was able to inspect the contactor and observed a brown discoloration. The cause of the discoloration is attributed to an electrical short condition due to loose wiring at a contactor terminal. The steris service technician replaced the contactor, ran a test cycle and returned the unit to service. No additional issues have been reported. The caviwave ultrasonic cleaner was installed in 2013 and is serviced and maintained by the user facility's 3rd party maintenance provider. The cause of the loose wiring is attributed to lack of preventive maintenance. The steris service technician found five contactor terminal screws required a half turn before they were found to be tight. The preventive maintenance guide states (2x/year), "verify all wire terminal ends at all terminals, terminal strips, relays, contactors, plc and connections are correctly installed, secure, and properly torqued. Ensure no wires show any signs of overheating or discoloration. " a steris district service manager (dsm) stated the user facility's 3rd party maintenance provider has purchased the maintenance manuals and have conducted their own biomedical training on the caviwave cleaners.
Patient Sequence No: 1, Text Type: N, H10
[89936295]
The user facility reported that a burning smell was emitting from their caviwave ultrasonic cleaner. No report of injury, procedure delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2017-00007 |
| MDR Report Key | 6918432 |
| Date Received | 2017-10-05 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-09-07 |
| Date Added to Maude | 2017-10-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Street | 6100 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAVIWAVE PRO ULTRASONIC CLEANING SYSTEM |
| Generic Name | CLEANING SYSTEM |
| Product Code | FLG |
| Date Received | 2017-10-05 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Address | 6100 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-05 |