MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-26 for CAVIWAVE PRO ULTRASONIC manufactured by Steris Corporation - Distribution Center.
[6058543]
The user facility reported the control panel wires in their caviwave pro ultrasonic unit caught on fire. The user facility was able to extinguish the reported fire. No report of injury. The fire alarm did not sound and no evacuations were required.
Patient Sequence No: 1, Text Type: D, B5
[13958367]
A steris field service technician arrived onsite, inspected the unit, and identified the charred wires. The unit has been removed from service and sent to the manufacturer for repairs. The user facility has been provided a loaner unit. Steris service engineering has reviewed the reported event and determined it is likely the wire connections near the control panel loosened over time and caused the reported event. Per section 4: preventive maintenance of the caviwave pro ultrasonic's operator manual, "verify all electrical connections and terminals are tight and secure," at least twice a year. The steris technician discussed maintenance of the unit with the user facility's clinical engineering staff. Steris has conducted in-service training.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003950207-2015-00004 |
| MDR Report Key | 4871362 |
| Report Source | 06 |
| Date Received | 2015-06-26 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-05-29 |
| Date Mfgr Received | 2015-05-29 |
| Date Added to Maude | 2015-06-26 |
| 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 KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVIWAVE PRO ULTRASONIC |
| Generic Name | ULTRASONIC CONSOLE |
| Product Code | FLG |
| Date Received | 2015-06-26 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Address | 6100 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-26 |