MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for LOKOMAT LOKOMAT PRO NA manufactured by Regulatory Insight, Inc..
[40856367]
Patient Sequence No: 1, Text Type: N, H10
[40856368]
Patient was removed from the equipment, and hocoma support was contacted. Support walked writer through a calibration process. The patient was again set up in the lokomat, and gait training was initiated. Within 5 min of starting training, the lokomat pc alerted the user that it was "rebooting now". The machine shut down with the patient on the treadmill within the robotic system. The two above listed witnesses were called to assist with removal of the patient from the system. The manual/emergency release of the overhead harness system was initiated, but it required the addition of writer's weight on the hanger/pulley in order to lower the patient to his wheelchair. The system would not lower completely to the wheelchair seat, but dismount was able to be achieved with the use of the seat elevator function on the patient's wheelchair. The lokomat system could not be restarted on this day. ====================== manufacturer response for exerciser, exerciser (per site reporter) ====================== unknown. Company is aware of ongoing issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5515915 |
| MDR Report Key | 5515915 |
| Date Received | 2016-03-22 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-10-29 |
| Report Date | 2016-02-15 |
| Date Reported to FDA | 2016-02-15 |
| Date Reported to Mfgr | 2016-02-15 |
| Date Added to Maude | 2016-03-22 |
| 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 | LOKOMAT |
| Generic Name | SYSTEM, ISOKINETIC TESTING AND EVALUATION |
| Product Code | IKK |
| Date Received | 2016-03-22 |
| Model Number | LOKOMAT PRO |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REGULATORY INSIGHT, INC. |
| Manufacturer Address | 33 GOLDEN EAGLE LANE LITTLETON, CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-22 |