MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-20 for WM-NP1 220-240V UK A/S K10000286 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[138419056]
Outcome of olympus keymed investigation: the customer fitted an unauthorised replacement mains lead to a workstation. The wall connection plug of this lead was inadequate for the task and failed with an internal electrical discharge between the live and earth connections. The power was lost to the olympus transformer and the remainder of the equipment mounted on, and supplied by, the workstation stopped functioning through lack of power. No one was injured or harmed following the event. This will be the final follow up report, however if any new information is provided the case will be re-opened and investigated further. Fault caused by non olympus product.
Patient Sequence No: 1, Text Type: N, H10
[138419057]
(b)(6) 2019 the plug that exploded was identified by the hospital as one that they had supplied not olympus. The monitor went blank mid procedure, also the power button on the workstation was 'out'. The procedure was completed with another stack system and the patient was unharmed. The medical physics department took the faulty stack out of the room and plugged it into the mains which is when the nurse heard a bang and the plug exploded. The mains lead was blue. It was also noted that the plug was cut open by the field service engineer to extract the burnt contacts. It wasn't blown open when the plug went bang as the photos suggest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2019-00010 |
| MDR Report Key | 8354245 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2010-02-17 |
| Date Added to Maude | 2019-02-20 |
| 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 SS25QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS25QH |
| Manufacturer Phone | 0441702616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WM-NP1 220-240V UK A/S |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2019-02-20 |
| Model Number | K10000286 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 SS2 5QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |