MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for WM-NP1 220-240V UK A/S K10000286 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[132539731]
Olympus keymed sales business centre (s-bc) were contacted about this event by the mhra. According to the event description, the device was used despite a repair being incomplete. The workstation should have been quarantined until the repair was completed. There was no report of injury to patient or user, however, the patient did go through an unnecessary anaesthesia and was caused stress. As this is a servicing issue olympus keymed s-bc investigating further and a follow up mdr will be submitted once more information is provided. Reported in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[132539732]
On (b)(6) 2018 10:38:07 (b)(6): mhra adverse incident report. Patient was admitted for an endoscopy procedure under general anaesthetic. Patient was anaesthetised for procedure but unfortunately after intubation the equipment failed before her colonoscopy procedure could take place and the procedure was abandoned. The patient was woken from anaesthetic and extubated. The patient is medically high risk with various co-morbidities and an asa score of iii. This patient has had an unnecessary general anaesthetic and had to come off her anticoagulation and had taken bowel laxatives. The patient was upset but politely and with dignity accepted the apology and acknowledged the fact that she will have to go through the stress of the procedure again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2019-00008 |
| MDR Report Key | 8226348 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2019-01-25 |
| Device Manufacturer Date | 2006-03-28 |
| Date Added to Maude | 2019-01-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 SS25QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS25QH |
| Manufacturer Phone | 0441702616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WM-NP1 220-240V UK A/S |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2019-01-08 |
| Model Number | K10000286 |
| 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 | 2019-01-08 |