MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-22 for CAVIWAVE ULTRASONIC CONSOLE manufactured by Steris Corporation - Distribution Center.
[29254816]
A steris field service technician arrived onsite, inspected the unit, and identified a leak at the hose connection for the pump. The technician identified that two of the sonic generators were damaged and not operating properly. The wires evidenced signs of charring. No burning smell or fire was reported by the user facility. The technician repaired the reported leak at the connection. The unit is being returned for further evaluation. The investigation of this event is currently in process. A follow up mdr will be submitted once additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[29254817]
The user facility reported their caviwave ultrasonic console was leaking water. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[40981797]
This device subject of the reported event is manufactured by a third party. The manufacturer evaluated the unit and concluded that the charred wiring was a result of terminal wires being improperly secured; the screws used to secure the wires to the terminal blocks were found to be loose. Arcing of the terminals when the unit was operating produced a large amp spike resulting in the melted terminal blocks and charred wires. During the manufacturer's evaluation the user facility received a loaner unit. The user facility declined to have the unit subject of the reported event repaired. The user facility purchased the loaner unit; no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003950207-2015-00006 |
| MDR Report Key | 5168216 |
| Date Received | 2015-10-22 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-09-28 |
| Date Mfgr Received | 2015-09-28 |
| Date Added to Maude | 2015-10-22 |
| 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 | 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 ULTRASONIC CONSOLE |
| Generic Name | ULTRASONIC CONSOLE |
| Product Code | FLG |
| Date Received | 2015-10-22 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-10-22 |