MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-09-23 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004061 manufactured by Independence Technology, L.l.c..
[938568]
User reported a sideways fall when climbing a curb in 4-wheel function onto a grassy area that was slick. User stated that one tire grabbed and the other tire slipped, causing the device to spin and fall sideways. User states that he hurt his shoulder and was going to have an x-ray to determine injury, and that there was damage to the left front light assembly on the device. User stated that he was wearing the provided lap belt at the time of the event. In later follow-up, the user stated that he sustained a dislocated shoulder and his doctor suggested that he may have torn his rotator cuff. User states that he plans to see a specialist in "a couple of weeks" (exact time frame was not provided). The user's physical therapist recommended that he ice his shoulder. This report corresponds to independence technology complaint # (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[8264474]
Service was dispatched to inspect the device and retrieve a copy of the electronic configuration file (ecf) for review. A report on field service activity/device checkout record (esar) was forwarded to the complaint handling unit (chu) per standard operating procedure. Inspection by the service representative noted slight damage as a result of the reported event, but determined that the device passed all functionality checks and was appropriate for use. Ecf data review confirms that the device was climbing a curb or step in the forward direction in 4-wheel function, that the device seat position was near the maximum allowed for that function, and that the front wheels successfully climbed onto the obstacle. Wheel command and velocity comparisons showed several instances of differing levels of traction loss between left and right wheels. The device rocked back and forth as the user attempted to continue climbing the obstacle. The device then rolled to one side until the safety limit was reached. Ecf data is consistent with the owner's description of the event. Due to a loss of traction control, the device became turned laterally on a step or curb and rolled to one side. Product labeling specifies that slipper/wet obstacles are unacceptable surfaces for 4-wheel function, and that low seat heights are recommended for greater stability. There were no other product faults in the log which would have contributed to this event. Ecf data confirmed that the product did not malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00009 |
| MDR Report Key | 1178117 |
| Report Source | 04 |
| Date Received | 2008-09-23 |
| Date of Report | 2008-09-23 |
| Date of Event | 2008-09-11 |
| Date Mfgr Received | 2008-09-11 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2010-06-12 |
| 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 | ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| 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 | 2008-09-23 |
| Model Number | NA |
| Catalog Number | IT004061 |
| 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 | 2008-09-23 |