MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-11 for WM-NP1 220-240V ROW K10000288 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[100133095]
No report of injury to patient or user. Field service engineer (fse) has attended and carried out full testing. No fault found, and has advised that wm-np1 trolley and an ofp-2 (flushing pump) which was being used during the same procedure ((b)(4)) is fit for use. Fse explanation for the fault is a temporary interruption in the room power. Reported in abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[100133096]
Red lines on screen and sparks coming from back of machine, screen went blank. Abandoned procedure. (b)(6) 2018 - jrb - update from field service engineer. Has been in today and stripped light source, processor and done all expected tests and found no fault with our product. My only explanation for the fault is a temporarily interruption in the room power. I have soak tested the product for over an hour with no fault found. I have stated to (b)(6) (charge nurse), the equipment in my opinion is fit for use.
Patient Sequence No: 1, Text Type: D, B5
[116925107]
The subject device will not be returned to the manufacturer, as an olympus field service engineer has attended the healthcare facility and tested the subject device. The field service engineer found no fault with the subject device. Investigation into this event will be closed however if any new information is provided the investigation will be re-opened. This event is reported in an abundance of caution. This will be the final follow up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2018-00004 |
| MDR Report Key | 7262613 |
| Date Received | 2018-02-11 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-03-14 |
| Device Manufacturer Date | 2008-09-05 |
| Date Added to Maude | 2018-02-11 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 0441702616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WM-NP1 220-240V ROW |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2018-02-11 |
| Model Number | K10000288 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-11 |