MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-24 for WM-NP2 WORKSTATION SET 2 (US) K10021769 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[143453950]
The cart was not returned to olympus for evaluation. The cause of the reported event cannot be determined; however, the wm-p2 instruction manual warns users? Check the security and condition of castors at six-monthly intervals. If loose and/or excessively worn, contact olympus for service. It is important to perform the maintenance described in this chapter? Chapter 6 care, inspection, storage and maintenance? To ensure the workstation and accessories remain in a good and safe working condition. Safety cannot be guaranteed if maintenance is neglected.
Patient Sequence No: 1, Text Type: N, H10
[143453951]
Olympus was informed that while pushing the workstation down the user facility? S hallway the castor wheel broke off causing the cart to tip and fall on its side. The user facility reported that the castor had been replaced a week prior to the incident. The cart brushed against the staff pushing the cart; however, there was no injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00768 |
| MDR Report Key | 8547418 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-24 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WM-NP2 WORKSTATION SET 2 (US) |
| Generic Name | WM-P2 WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2019-04-24 |
| Model Number | K10021769 |
| 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 | 2019-04-24 |