MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-10 for CREST ULTRASONIC CONSOLE manufactured by Steris Corporation - Distribution Center.
[20068301]
The user facility reported their crest ultrasonic console was leaking water onto the floor. An employee slipped on the water, fell, and sought medical treatment for knee pain. No report of procedural delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
[20247092]
A steris field service technician arrived onsite, inspected the unit, and identified a crack on the side of the adapter at the soap injection area. Water was able to escape through the crack and leak onto the floor. The technician replaced the adapter and fittings, tested the unit, and returned the unit to service. The employee subject of the reported event did not miss work due to the reported injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003950207-2015-00002 |
| MDR Report Key | 4681930 |
| Report Source | 06 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-03-18 |
| Date Added to Maude | 2015-05-12 |
| 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 | CREST ULTRASONIC CONSOLE |
| Generic Name | CREST SONIC |
| Product Code | FLG |
| Date Received | 2015-04-10 |
| 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 | 2015-04-10 |