MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-03 for MAJ-173 TRANSFORMER WM-T1 100V K10000289 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[119506874]
The fuse and terminal in the transformer was burned and damaged. No report of injury to patient or user as this was discovered during a pre-service inspection. Olympus (b)(4) have requested that the transformer is returned for further investigation. Reported in an abundance of caution and further information will be provided within a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[119506875]
Google translation: as a result of "fuse breakage" pointed out to sorc nagano as a repair request, the terminal part of the fuse was inspected and confirmed to be burned and damaged. The condition that the connection terminal of the fuse holder was also burned and damaged. Checking with the local fs personnel, they advised that no health damage occurred following a discovering of the malfunction in pre-service inspection. Health damage has not occurred but because the connection terminal of the fuse holder is burned out, it may fall under the item of "safety management information pocket guide", so it was reported to the medical safety division and the etq raised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00014 |
| MDR Report Key | 7840763 |
| Date Received | 2018-09-03 |
| Date of Report | 2018-10-08 |
| Date Mfgr Received | 2018-10-03 |
| Device Manufacturer Date | 2008-09-04 |
| Date Added to Maude | 2018-09-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR PETER MORCOS |
| Manufacturer Street | KEYMED HOUSE, STOCK ROAD |
| Manufacturer City | SOUTHEND ON SEA, ESSEX SS25QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS25QH |
| Manufacturer Phone | 0441702616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAJ-173 TRANSFORMER WM-T1 100V |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2018-09-03 |
| Model Number | K10000289 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
| Manufacturer Address | KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA, ESSEX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-03 |