MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-05 for CPM MACHINE manufactured by Klc Services Inc..
[22967921]
When unplugging a cpm machine, the transformer came apart exposing the wiring inside. The transformer shorted and caused sparking. No harm to staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055339 |
| MDR Report Key | 5001318 |
| Date Received | 2015-08-05 |
| Date of Report | 2015-08-05 |
| Date of Event | 2015-08-04 |
| Date Added to Maude | 2015-08-13 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPM MACHINE |
| Generic Name | CPM MACHINE |
| Product Code | BXB |
| Date Received | 2015-08-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KLC SERVICES INC. |
| Manufacturer Address | HILLIARD OH 43026 US 43026 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-05 |