MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-18 for MAJ-113 TRANSFORMER WM-260 JP K7503987 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[114689035]
No reports of alleged injury to patient or user has been identified for this complaint. Risk assessment for the transformer has been reviewed and confirmed that the workstation transformer has been safety tested to iec 60601-1. Further information will be provided within the follow-up report. The wm-p1 series is discontinued however is still supported through servicing activities. A request has been sent for the return of the product for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[114689036]
A spark came out from the power plug of the isolation transformer (maj - 113) during inspection. It was pulled out from the outlet, and the metal part had melted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00012 |
| MDR Report Key | 7698003 |
| Date Received | 2018-07-18 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-06-27 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2002-01-06 |
| Date Added to Maude | 2018-07-18 |
| 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-113 TRANSFORMER WM-260 JP |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2018-07-18 |
| Returned To Mfg | 2018-06-29 |
| Model Number | K7503987 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-07-18 |