MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for WM-NP1 220-240V EU K10000287 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[182290573]
Olympus (b)(6) were notified of this event for information purposes only. No product will be returned for further investigation as the event occured over 2 years ago. The failure mode is a broken castor, however, no root cause can be determined as neither the workstation or the castor will be returned to olympus (b)(6) for further investigation. The event occurred in (b)(6) 2018 and since this date the wm-np1 workstation has been repaired. This report will be the initial and final report. If any new information is provided the case will be reviewed. Reported in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[182290574]
The nurse at the facility advised that a wheel (castor) broke off the workstation some time ago. The estimated time of the event is around (b)(6) 2018, however this can not be confirmed. There was no report of injury to patient or user and the workstation was kept upright by the nursing staff. The wm-np1 workstation has been repaired since the alleged date of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2020-00011 |
| MDR Report Key | 9739132 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-21 |
| 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-NP1 220-240V EU |
| Generic Name | WM-NP1 220-240V EU |
| Product Code | FEM |
| Date Received | 2020-02-21 |
| Model Number | K10000287 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-21 |