MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-09-02 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004708 manufactured by Independence Technology, Llc.
[1136570]
User reported that the device auto-transitioned from balance to 4-wheel function while he was working in a store. User stated that while driving, the device in balance function, the armrest fell off the device and when attempted to catch it, the device auto transitioned to 4-wheel function, becoming caught on a nearby obstruction (lawn mower), causing the product to fall over to the left. User reported that his left foot was caught between the wheel cluster and main chassis of the device when it fell. User reported that he sustained a broken left foot and a hematoma on his hip, along with multiple abrasions to his hands and arms. User was treated at a local hospital, but declined to be admitted ama and was released. User declined to provide any treatment related information such as doctor or hospital name, etc. , citing privacy regulations. Refer to attachment i for additional narrative. This report corresponds to independence technology complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8314726]
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 for 799 meters and 45 minutes prior to the event. The device then recorded a general controller alert warning of pitch nearing threshold and auto-transitioned to 4-wheel function. Within 1 second, 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 black box data confirms the device was driving forward and turning slightly when a series of pitch disturbances caused the device to issue a controller alert and auto-transition to 4-wheel function. During the cluster rotation which takes place during this transition, the lateral roll angle of the device sharply fell outside the 50 degree limit. 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 | 3003508375-2009-00007 |
| MDR Report Key | 1463336 |
| Report Source | 04 |
| Date Received | 2009-09-02 |
| Date of Report | 2009-09-01 |
| Date of Event | 2009-08-26 |
| Date Mfgr Received | 2009-08-27 |
| 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, DIRECTOR |
| Manufacturer Street | ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9087223767 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERVICES |
| Manufacturer Street | 7444 HAGGERTY ROAD |
| 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 | 2009-09-02 |
| 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 | 2009-09-02 |