MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for LOKOMATPRO manufactured by Regulatory Insight, Inc. (hocoma Ag).
[51019242]
Patient Sequence No: 1, Text Type: N, H10
[51019243]
When using lokomat, had patient in harness and strapped into orthotic. Attempted to start machine, and four error codes were generated. Attempted to restart, same error codes generated, requiring reboot of the machine. The patient was removed from the device, and unable to complete the treatment. No injury to the patient, no potential for injury to the patient. Prior to reboot, attempted to run the machine without a patient in it, and same error codes were generated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5842672 |
| MDR Report Key | 5842672 |
| Date Received | 2016-08-03 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-05-12 |
| Report Date | 2016-07-20 |
| Date Reported to FDA | 2016-07-20 |
| Date Reported to Mfgr | 2016-07-20 |
| Date Added to Maude | 2016-08-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | LOKOMATPRO |
| Generic Name | SYSTEM, ISOKINETIC TESTING AND EVALUATION |
| Product Code | IKK |
| Date Received | 2016-08-03 |
| Model Number | LOKOMATPRO |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REGULATORY INSIGHT, INC. (HOCOMA AG) |
| Manufacturer Address | 33 GOLDEN EAGLE LANE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-03 |