MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-12 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004706 manufactured by Independence Technology, L.l.c..
[2156603]
User reported that she was at a bar drinking water and experienced a forward fall from the device while attempting to transition from balance to 4-wheel function. User states that she went backwards to make room for the transition. When she proceeded with the transition to 4-wheel, she states a broken right front light got caught in the moving parts and the device fell forward. User was not wearing the provided lap belt - states it was damaged. It is noted that neither of these damaged parts were reported prior to the event. User states she fell forward ahead of the device and the device fell on top of her. User was transported by emt's to the er and x-rays were taken of her injured right leg. After x-rays and being seen by an er doctor, user was taken home for bed rest. It was noted that the injured leg was not placed in a cast. User stated that she may have broken her right leg - tibia and fibula. Later f/u with her pcp did not confirm any such injury and user was advised to avoid putting any weight on the leg for 2 to 4 weeks. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9477771]
Service was dispatched to inspect the device, retrieve the electronic configuration file (ecf) for eval, and clear the service wrench. A field service activity / device checkout report (esar) was forwarded to the complaint handling unit (chu) per standard operating procedure. The esar confirmed the reported damage to the light assy and lap belt which were replaced in a separate service activity. The device was deemed appropriate for use. Ecf analysis indicates the device was in balance function with the seat height at mid-range for approx. 1 hr 45 minutes, traveling a distance of 14 meters when a series of frame lean adjustments and seat height adjustment resulted in cluster drive ab reporting "warm". Another seat height adjustment was made elevating the seat to maximum, and the device then reported cluster motor ab as "warm". Within 5 seconds the device reported cluster motor ab as "hot", and initiated an auto-transition to 4-wheel due to a motor hot condition. Two seconds later the device went to a controller failure condition because it exceeded its pitch limit. No other alarms were present in the logs that would have contributed to this event. Black box data shows that during the event, the cluster position was fixed, regardless of controller command and comparable motor current. The cluster drive and motor temperature steadily rose as the operator attempted to move the seat (height) and cluster (frame lean). The motor temp exceeded the threshold for balance and triggered the auto-transition. The mechanical movement of auto-transition rolls the wheels backward to hold position while the cluster rotates the front wheels down to the ground. With the cluster position constrained to the chassis, this normal wheel movement caused the device to pitch forward and result in the controller failure. In conclusion, the device did not malfunction, and behaved as expected. External environmental conditions constrained the cluster position, causing a motor hot condition and prevented the device from being able to maintain dynamic stabilization.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2011-00004 |
| MDR Report Key | 2253459 |
| Report Source | 04 |
| Date Received | 2011-09-12 |
| Date of Report | 2011-09-12 |
| Date of Event | 2011-08-25 |
| Date Mfgr Received | 2011-08-26 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2012-06-28 |
| 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 |
| 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 W., |
| Manufacturer City | SOMERVILLE 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2011-09-12 |
| Model Number | IBOT |
| Catalog Number | IT004706 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-12 |