MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for WM-NP2 WORKSTATION SET 3 (JP) K10020682 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[178743462]
Olympus keymed have requested the return of the burnt power cable for further investigation. There has been no report of injury to patient or user.
Patient Sequence No: 1, Text Type: N, H10
[178743463]
An electrical short circuit occurred on the power cord. The wm-np2 workstation was connected to the wall outlet of the facility during an upper digestive tract examination in the endoscope room. It was reported that the wm-np2 power cable burned. The switch at the rear of the transformer was switched off. The equipment was connected to an alternative power supply owned by the facility. The inspection continued. After this, about 10 cases were conducted.
Patient Sequence No: 1, Text Type: D, B5
[183516891]
Olympus keymed investigation found that no electrical short occurred. It was confirmed that the live pin of the mains connection cord had some small damage. The damage is consistent with an electrical arc being drawn following a failure of a wall socket or the inappropriate removal of the plug from the wall socket while the transformer is under load. It is presumed the plug on the mains cord was subjected to a force to cause it to be pulled from the wall by either movement of the workstation while in use (indicated against in the instructions for use) or by someone inadvertently interacting with the mains cord (trip due to user's routing of cord in the theatre). The cause has been determined to be user misuse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2020-00008 |
| MDR Report Key | 9568021 |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2012-10-31 |
| Date Added to Maude | 2020-01-09 |
| 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 3 (JP) |
| Generic Name | WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2020-01-09 |
| Model Number | K10020682 |
| 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 SS2 5QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |