MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-20 for FLEX MATE K500 manufactured by Klc Services.
[18014335]
While unplugging a cpm machine, the transformer came apart exposing the wiring inside. The staff member somehow contacted the wiring and was shocked. No harm to the staff member.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044710 |
| MDR Report Key | 4939061 |
| Date Received | 2015-07-20 |
| Date of Report | 2015-07-20 |
| Date of Event | 2015-07-15 |
| Date Added to Maude | 2015-07-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEX MATE K500 |
| Generic Name | EXERCISER |
| Product Code | BXB |
| Date Received | 2015-07-20 |
| Model Number | K500 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KLC SERVICES |
| Manufacturer Address | HILLIARD OH 43026 US 43026 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-20 |