MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-10 for CAVIWAVE PRO ULTRASONIC CLEANER manufactured by Steris Corporation - Distribution Center.
[5941105]
The user facility reported that water was leaking from their caviwave pro ultrasonic cleaner. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[13458448]
A steris service technician inspected the unit and was unable to identify a leak. The technician tested the unit and was unable to duplicate the reported event. The technician confirmed the unit to be operating according to specification and returned it to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003950207-2015-00003 |
| MDR Report Key | 4835921 |
| Report Source | 06 |
| Date Received | 2015-06-10 |
| Date of Report | 2015-06-10 |
| Date of Event | 2015-05-12 |
| Date Mfgr Received | 2015-05-12 |
| Date Added to Maude | 2015-06-10 |
| 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 CLEANER |
| Generic Name | ULTRASONIC CLEANER |
| Product Code | FLG |
| Date Received | 2015-06-10 |
| 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 | 2015-06-10 |