MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-31 for ARTROMOT K3 P6915 manufactured by Hill-rom, Inc..
[71381629]
Patient Sequence No: 1, Text Type: N, H10
[71381630]
The rn was preparing the continuous passive motion (cpm) machine for placement on a patient. She could not get it to work. When she reached down to unplug the machine, the plug was very hot and she burned her left index finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6449267 |
| MDR Report Key | 6449267 |
| Date Received | 2017-03-31 |
| Date of Report | 2017-03-17 |
| Date of Event | 2016-07-27 |
| Report Date | 2016-09-30 |
| Date Reported to FDA | 2016-09-30 |
| Date Reported to Mfgr | 2016-09-30 |
| Date Added to Maude | 2017-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTROMOT K3 |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2017-03-31 |
| Model Number | P6915 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-31 |