MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-27 for LOKOMAT-SYSTEM 4.0 NA manufactured by Hocoma Ag.
[17375340]
Following 20 minutes of training a motor complete, chronic spinal cord injured patient at 2. 8km/hr and at 55kg of body-weight support, the unloading rope broke. The location of the break was approximately 16 inches above the horizontal corss bar located above the subject. The location of the break on the rope appeared to be at about the position the rope would be expected to be on the over-head pulley. Inspection of the rope at the location of the break revealed a brittle texture, as the rope had been subjected to high tempertures as might occur under friction conditions. No injuries resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003781275-2005-00001 |
| MDR Report Key | 598264 |
| Report Source | 05 |
| Date Received | 2005-04-27 |
| Date of Report | 2005-04-22 |
| Date of Event | 2005-04-15 |
| Date Mfgr Received | 2005-04-16 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2005-05-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN WALLS |
| Manufacturer Street | 13 RED FOX LANE |
| Manufacturer City | LITTETON CA 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * * |
| Manufacturer Country | * |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | 3003781275-04-22-2005-00 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOKOMAT-SYSTEM |
| Generic Name | POWERED EXERCISE EQUIPMENT |
| Product Code | ISD |
| Date Received | 2005-04-27 |
| Model Number | 4.0 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 588102 |
| Manufacturer | HOCOMA AG |
| Manufacturer Address | INDUSTRIESTRASSE 4 VOLKETSWIL SZ CH 8604 |
| Baseline Brand Name | LOKOMAT-SYSTEM |
| Baseline Generic Name | POWERED EXCERXIS EQUIPMENT |
| Baseline Model No | 4.0 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-27 |