MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-07-31 for OLYMPUS WM-NP1 WITH TRANSFORMER WM-NP1 220-240V EU K10000287 manufactured by Keymed Ltd..
[2732039]
During the transportation of the workstation, a wheel broke and the workstation fell to the side. Nobody was injured. The workstation, an olympus monitor, and another monitor for blood pressure were damaged.
Patient Sequence No: 1, Text Type: D, B5
[10087574]
The device referenced in this report is being returned to the manufacturer for evaluation. The device has not yet been received by the manufacturer. There was no report of injury to patient or user, however as a similar incident took place previously (manufacturer reference number 9611174-2011-00004) this report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2012-00010 |
| MDR Report Key | 2681355 |
| Report Source | 01 |
| Date Received | 2012-07-31 |
| Date of Report | 2012-07-30 |
| Date of Event | 2012-07-12 |
| Date Mfgr Received | 2012-07-16 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2012-11-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALISON PRIOR |
| Manufacturer Street | STOCK RD. KEYMED HOUSE |
| Manufacturer City | SOUTHEND-ON-SEA, ESSEX SS2 5QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS2 5QH |
| Manufacturer Phone | 170261633 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS WM-NP1 WITH TRANSFORMER |
| Generic Name | OLYMPUS MOBILE WORKSTATION |
| Product Code | FEQ |
| Date Received | 2012-07-31 |
| Model Number | WM-NP1 220-240V EU |
| Catalog Number | K10000287 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED LTD. |
| Manufacturer Address | STOCK RD. SOUTHEND-ON-SEA, ESSEX SS25QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-31 |