MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-09-01 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004708 manufactured by Independence Technology, Llc.
[1258281]
User reported that the device auto-transitioned from balance to 4-wheel function for an unk reason while he was in a store. User stated that the left rear wheel of the device struck a shelving unit while transitioning, which caused it to fall on its right side. User reported that he sustained two broken ribs when his chest struck the (b)(4). User was treated at a local hospital and released. User noted that he has lost approx 30lbs in weight since he was originally center of gravity (cg) fit for the device. Product labeling warns "... Never to operate the product if you have gained or lost more than 20lbs.. " as the "... Technology may not operate properly... " and that "... Personal injury or death could result... ". User had not contacted the company regarding his weight loss prior to this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8388025]
Service was dispatched to inspect the device and retrieve the electronic configuration file (ecf) for review. A report on field service activity (sar) and a device checkout record (fcr) was forwarded to the complaint handling unit (chu) per standard operating procedure. The ecf evaluation determined that the user was in balance function for 32 min 19 seconds, traveling 706 meters, prior to the event. At that time, the device recorded a controller alert indicating loss of traction in balance function and auto-transitioned to 4-wheel function. Two seconds later, the device went to a controller failure condition due to the lateral roll angle (50 degrees) being exceeded. There were no other product faults in the log which would have contributed to this event. The product logs are consistent with the description provided by the user. A loss of traction in balance function caused the device to auto-transition to 4-wheel. The device then likely impacted an obstacle and rolled to one side. The product does not have dynamic lateral stabilization and dynamic driving conditions can contribute to the device rolling laterally. In conclusion, the product did not malfunction and behaved as expected for the given conditions. The product auto-transitioned from balance to 4-wheel when conditions became too dynamic to maintain balance, and went to controller failure when the lateral roll angle exceeded its limit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2009-00006 |
| MDR Report Key | 1463979 |
| Report Source | 04 |
| Date Received | 2009-09-01 |
| Date of Report | 2009-08-31 |
| Date of Event | 2009-08-17 |
| Date Mfgr Received | 2009-08-17 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2010-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL O'MEARA, DIR |
| Manufacturer Street | ROUTE 22 WEST |
| Manufacturer City | SOMMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9087223767 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERVICES |
| Manufacturer Street | 7444 HAGGERTY RD |
| Manufacturer City | CANTON MI 48187 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48187 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2009-09-01 |
| Model Number | NA |
| Catalog Number | IT004708 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, LLC |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2009-09-01 |