MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for LOKOMAT LOKOMATPRO L6.1 28862 manufactured by Hocoma Ag.
[136268633]
The broken rope was sent back to the manufacturer for examination. Result of the examination was that the defect was caused by wrong insertion of the rope after replacement. The device had been moved by hocoma service technician one week before this event. The rope has been installed across a metal bar instead of being pulled through a feedthrough underneath this bar. As a result of this increased friction, the rope broke soon after taking the device into service again.
Patient Sequence No: 1, Text Type: N, H10
[136268634]
At the end of the training session, the patient is lifted to be taken out of the device. Body weight support rope breaks while lifting patient up. Patient (m, (b)(6) yr, (b)(6) kg) drops slightly. Is caught by clinician and pushed up. Two other clinicians came to help. Patient suffered no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003781275-2019-00001 |
| MDR Report Key | 8280867 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2011-12-22 |
| Date Added to Maude | 2019-01-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | HOCOMA AG |
| Manufacturer Street | INDUSTRIESTRASSE 4B |
| Manufacturer City | VOLKETSWIL, 8604 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LOKOMAT |
| Generic Name | SYSTEM, ISOKINETIC TESTING AND EVALUATION |
| Product Code | IKK |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-01-18 |
| Model Number | LOKOMATPRO L6.1 |
| Catalog Number | 28862 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOCOMA AG |
| Manufacturer Address | INDUSTRIESTRASSE 4B VOLKETSWIL, 8604 SZ 8604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |