MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-02 for WM-NP1 100V JP K10000284 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[96844835]
No injury to patient or user. Event occurred during pre surgical check. Procedure carried out with no further abnormalities. Most likely cause of event is user error - not checking that the workstation was turned off before removing cable from inlet. Reported in the abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[96844836]
Before inspection, spark occurred from inlet. (b)(4) olympus added by (b)(4). This event judged non-pae at first. However we re-judged this event is pae since a spark occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00001 |
| MDR Report Key | 7156470 |
| Date Received | 2018-01-02 |
| Date of Report | 2018-03-02 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2007-08-28 |
| Date Added to Maude | 2018-01-02 |
| 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 100V JP |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2018-01-02 |
| Model Number | K10000284 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-01-02 |