MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for WM-NP2 WORKSTATION SET 1 (EU) K10021765 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[136894792]
The olympus keymed investigation has been completed. The castor becoming loose initiated the failure sequence. There is no evidence of whether the castor security checking as defined in the maintenance and repair manual was followed. The mechanism causing the castor to come loose is unknown; therefore the true root cause cannot be determined at this time. There were no reports of injury to patient or user. This is the initial and final follow up report. However, if any new information is received the case will be reopened and investigated further.
Patient Sequence No: 1, Text Type: N, H10
[136894793]
The bolt on a castor broke from the base frame of a wm-np2 workstation. The castor was replaced on (b)(6) 2018 and was carried out according to the service manual. Nobody was hurt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2019-00009 |
| MDR Report Key | 8305211 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2015-04-21 |
| Date Added to Maude | 2019-02-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 1 (EU) |
| Generic Name | WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2019-02-05 |
| Model Number | K10021765 |
| Device Availability | N |
| 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 | 2019-02-05 |