MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for LOKOMAT NA manufactured by Regulatory Insight, Inc..
[40856423]
Patient Sequence No: 1, Text Type: N, H10
[40856424]
Patient was being raised in the lokomat by the winch and the winch automatically went downward. Stop button needed to be pushed. Patient was ambulating in the lokomat and error messages came on 4 times without any explanations. Treatment need to be stopped using the lokomat legs. Manufacturer response for exerciser, exerciser (per site reporter): unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5515914 |
| MDR Report Key | 5515914 |
| Date Received | 2016-03-22 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-10-22 |
| 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 |
| Catalog Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 8 YR |
| 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 |