MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-09-23 for RELIANCE TABLETOP ULTRASONIC WASHER manufactured by Steris Corporation - Distribution Center.
[26594557]
A steris service technician arrived at the user facility, and was informed the employee had inadvertently dropped the lid of the reliance tabletop ultrasonic cleaner down between the wall and the unit's electrical plug. The lid then made contact with the metal plug spades causing an electrical arcing condition. The employee went to retrieve the ultrasonic cleaner's lid and was shocked in the process. Following the reported event, the technician completed a full evaluation of the reliance ultrasonic cleaner and confirmed the only repair required was to the unit's lid which had partially melted due to the reported event. The technician has ordered the necessary components to repair the ultrasonic cleaner and will return to complete the repairs once the parts are available. While on site, the technician informed the facility's biomed department to repair and replace the electrical plug and outlet which the ultrasonic cleaner connects to and to verify all electrical outlets and connections at the facility are operating according to specification. The unit was installed on (b)(6) 2014 and is not under a steris service contract.
Patient Sequence No: 1, Text Type: N, H10
[26594558]
The user facility reported their reliance tabletop ultrasonic cleaner had an electrical arc, damaging the lid of the washer. An employee received a shock due to the issue reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2015-00005 |
| MDR Report Key | 5098853 |
| Report Source | USER FACILITY |
| Date Received | 2015-09-23 |
| Date of Report | 2015-09-23 |
| Date of Event | 2015-08-31 |
| Date Mfgr Received | 2015-08-31 |
| Date Added to Maude | 2015-09-23 |
| 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 | RELIANCE TABLETOP ULTRASONIC WASHER |
| Generic Name | ULTRASONIC CONSOLE |
| Product Code | FLG |
| Date Received | 2015-09-23 |
| 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 | 2015-09-23 |