MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-01-29 for CAVIWAVE PRO ULTRASONIC CONSOLE manufactured by Steris Corporation - Distribution Center.
[37144230]
A steris field service technician arrived onsite, inspected the unit, and identified the user facility's water pressure was above the recommended specifications for operation. The technician recorded the facility's water pressures over 100 psi. The force of the water pressure allowed for an o-ring on the filter housing to fail causing the reported water leak. Section 2 of the operator manual for the caviwave pro ultrasonic cleaner states, "other facility requirements: [hot, cold, and deionized water]: 38 psi maximum. " it was confirmed that upon installation, the water pressure specifications were within the recommended range for operation. The technician replaced the filters and o-ring, tested the unit, and confirmed it to be operating according to specification. The technician advised the user facility to install a pressure regulator to account for fluctuations in water pressure. Since the reported event, the user facility has installed a pressure regulator as recommended by the steris field service technician.
Patient Sequence No: 1, Text Type: N, H10
[37144231]
The user facility reported their caviwave pro ultrasonic cleaner was leaking water. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2016-00001 |
| MDR Report Key | 5398589 |
| Report Source | USER FACILITY |
| Date Received | 2016-01-29 |
| Date of Report | 2016-01-29 |
| Date of Event | 2015-12-31 |
| Date Mfgr Received | 2015-12-31 |
| Date Added to Maude | 2016-01-29 |
| 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 PRO ULTRASONIC CONSOLE |
| Generic Name | ULTRASONIC CONSOLE |
| Product Code | FLG |
| Date Received | 2016-01-29 |
| 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 | 2016-01-29 |