MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for WM-NP2 WORKSTATION SET 1 (JP) K10021766 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[88076114]
Okm has requested the return of the product for full investigation. There has been no report of patient injury. Report submitted in the abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[88076115]
After inspection, spark occurred from inlet when the cable was pulled put.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2017-00006 |
| MDR Report Key | 6904059 |
| Date Received | 2017-09-29 |
| Date of Report | 2018-03-05 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2018-02-23 |
| Device Manufacturer Date | 2013-09-18 |
| Date Added to Maude | 2017-09-29 |
| 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-NP2 WORKSTATION SET 1 (JP) |
| Generic Name | WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2017-09-29 |
| Returned To Mfg | 2017-09-11 |
| Model Number | K10021766 |
| Device Availability | R |
| 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 | 2017-09-29 |