MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-06-23 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004707 manufactured by Independence Technology, L.l.c..
[18968851]
User reported that he sustained 18 stitches and 2 broken ribs as a result of a backwards fall of the device which was outdoors in 4-wheel function. When asked, the user declined to provide any further details on his injuries and/or medical treatment sought / obtained, citing hippa. The user states that he was outside in mud in 4-wheel function and his device became stuck in the mud and started to sink. User states that he was trying to get the device out of the mud and he then started to rock the device forward and back to free it. User states that the device transitioned to balance function and fell backwards. He further states that he tried to break the fall and he fell sideways hitting his head on bricks of the driveway, causing him to sustain the reported injuries. The user states that he did not seek assistance from anyone at the time of the event, but rather made his way indoors and got into his other wheelchair. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18990597]
Service was dispatched to inspect the device and retrieve the electronic configuration file (ecf) for review and analysis. A report on field service activity and device checkout record (esar) was forwarded to the complaint handling unit (chu) per standard operating procedure. From the cfc review, the device entered 4-wheel function and was operated at the minimum seat height for 47 meters. After 1 minute 26 seconds, the device seat was elevated to the maximum seat height and operated for an add'l one minute 24 seconds, traveling 28 meters. At that time, the device went to a controller failure condition due to the balance metric exceeding its limit, while in 4-wheel function. The balance metric is a function of pitch, pitch rate, wheel speed, and dynamic state of the device. No other alarms were present in the logs which would have contributed to this event. The black box data shows that just prior to the event, the device was stable in 4-wheel function on a slightly uneven surface (7 degree pitch, and 5 degree roll angle). The data then clearly shows that pitch disturbance caused the wheel cluster angle to change abruptly, at which time both left and right wheels lost traction. These events together triggered the device to enter a controller failure condition due to exceeding the balance metric limitations. The customer description of the device entering balance function prior to falling is likely due to the increased cluster angle as the device attempted to maintain balance with the wheels stuck. The device did not malfunction and behaved as expected. Rocking/ interfering with the device while in a constrained condition with questionable traction such as mud, sand, or snow can result in exceeding the device's ability to maintain stability.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2010-00002 |
| MDR Report Key | 1737594 |
| Report Source | 04 |
| Date Received | 2010-06-23 |
| Date of Report | 2010-06-23 |
| Date of Event | 2010-06-14 |
| Date Mfgr Received | 2010-06-15 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2011-04-20 |
| 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 | 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 | 2010-06-23 |
| Model Number | IBOT 4000 |
| Catalog Number | IT004707 |
| 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, L.L.C. |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-23 |