MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for TRANSFORMER SPARE MAJ-173 K10006316 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[101720514]
The event reported is that the transformer started to burn and then shut down. Reference the photos provided there is scorch mark on the underside of the device. (b)(4) has requested the return of the device for further investigation. There has been no report of injury to patient or user. Reported in the abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[101720515]
The transformer burned and shut down when operation. No health injury occurred with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00005 |
| MDR Report Key | 7312421 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-04-24 |
| Date Mfgr Received | 2018-04-11 |
| Device Manufacturer Date | 2008-02-20 |
| Date Added to Maude | 2018-03-05 |
| 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 | MRS ALISON PRIOR |
| 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 | TRANSFORMER SPARE MAJ-173 |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2018-03-05 |
| Returned To Mfg | 2018-02-15 |
| Model Number | K10006316 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-03-05 |