MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-11-20 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004000 manufactured by Independence Technology, L.l.c..
[20512494]
Caller reported a user fall from the device. User was in the ibot traveling from a sidewalk to a parking lot. The surface was wet due to rain. The caller can not tell me what function the device was in. The user was trying to go over a low curb when the device would not move. The caller states the user then got the device to move, but it lurched forward, traveled 10 feet and stopped suddenly, throwing the user onto the ground, face first. The user was not wearing the provided lap belt. Caller reported the user suffered cuts to the forehead that required stitches, facial contusions, a cracked tooth and a swollen lip. The user was treated in the emergency room and sent home where he is resting now. The caller states the user was unconscious briefly, but has undergone a complete physical and was not admitted. The caller states the device does not appear to be damaged, but does have a service wrench on the display and limited function. Caller would like to arrange for service to restore all functions.
Patient Sequence No: 1, Text Type: D, B5
[20835272]
Service was dispatched to retrieve the device's ecf file for analysis to help determine circumstances surrounding the reported event. A report on field service activity (sar) and a device checkout record (fcr) were forwarded to the complaint handling unit (chu) per standard operating procedure. The user has not reported any recurrence of the described event since the completion of the service activity. Follow up with the user determined the following: the ibot was in 4 wheel drive. The customer moved the ibot forward to go over a curb, which he believes is less than 5 inches high. It was raining. The wheels started to spin, making it difficult to drive over the curb. When the wheels finally caught, the device sped down the curb and continued on approximately 20 yards in speed setting 2. The customer stated that he attempted to stop the device by pulling back on the joystick, but the joystick caused no response in the device. The customer does not remember the fall. He states that he woke up on a stretcher, being placed into an ambulance. He had been unconscious. His son told him that the device never tipped over. All 4 wheels were on the ground. The device did not run into anything. The device did stop suddenly at the end of the 20 yards, throwing the customer from it. The result of the ecf (electronic configuration file) analysis determined the following: the incident appears to have resulted from a very specific combination of factors. In particular, descending the curb at a specific rate of speed, releasing the joystick in the middle of that curb descent. In 4 wheel function, the ibot uses wheel movement in addition to cluster movement to maintain balance. When the front wheels drive off the curb, the ibot tilts forward, so the ibot drives the wheels forward to maintain balance. As the back wheels drive off the curb, the ibot may tilt backwards, causing the wheels to drive backwards to maintain balance. Stopping short when driving off a curb does not give the ibot much space to drive backwards, so it may "trip' over the curb as it is trying to maintain balance. The user may not have noticed, but the wheels were driving back against the curb when the event occurred. The wet ground allowed the wheels to spin. As the wheels spun, the cluster raised towards vertical as the ibot attempted to maintain its balance. At this instant, the balance point shifted in front of the two wheels on the ground. The ibot then moved forward in an effort to regain its balance. Before the ibot was able to achieve this, a total system shutdown occurred. At this point, the ibot came to a stop, turning off all motors. Investigation of the event and device response continues at this time. However, based on the informatin available so far, it does not appear the device malfunctioned. Rather, the device responded to the abnormal curb descent, and the operational inputs to the device. The device attempted to regain a steady attitude (balance) per design, and when this could not be achieved within a predetermined distance, the device went to total system shutdown, per design.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2006-00007 |
| MDR Report Key | 785784 |
| Report Source | 04 |
| Date Received | 2006-11-20 |
| Date of Report | 2006-11-17 |
| Date of Event | 2006-10-21 |
| Date Mfgr Received | 2006-10-21 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-11-24 |
| 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 | MICHAEL O'MEARA, DIRECTOR |
| Manufacturer Street | 45 TECHNOLOGY DRIVE |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084122200 |
| 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 | OT |
| 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 | 2006-11-20 |
| Model Number | NA |
| Catalog Number | IT004000 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 773583 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | 45 TECHNOLOGY DR. WARREN NJ 07059 US |
| Baseline Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Baseline Generic Name | STAIR CLIMB9NG WHEELCHAIR |
| Baseline Model No | NA |
| Baseline Catalog No | IT004000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-20 |