MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for WM-NP2 WORKSTATION SET 4 (JP) K10021610 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[184889590]
Olympus keymed have requested that the power cable is returned for further investigation. A follow up report will be submitted once an investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[184889591]
The wm-np2 workstation was plugged into the facilities mains during preparation for use. Fire and smoke came from the plug on the power cable. One pin of the outlet terminal (plug) is missing - it appears to have melted. The operation was conducted using another workstation. There was no patient health damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2020-00013 |
| MDR Report Key | 9780641 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-03 |
| 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 | 3 |
| Brand Name | WM-NP2 WORKSTATION SET 4 (JP) |
| Generic Name | WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2020-03-03 |
| Model Number | K10021610 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 SS2 5QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |