MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-11-05 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004701 manufactured by Independence Technology, Llc.
[16043711]
User reported that she was at an event on ((b)(6) 2010) and she decided to show people how the device dithers in balance function. User stated that someone lightly pushed/tapped the device and that the device moved forward very fast and went approx 8-9 feet. User stated that, when the device stopped, she fell from the device. User stated that she was not wearing the provided lap belt at the time of the event. User stated that, while in balance, the device fell over forward. User stated that she was taken by ambulance to the er for shoulder pain, neck pain and a broken nose. The user did not have x-rays. At the time that the event was reported to the company on (b)(6) 2010, the user stated that she had a black eye and may seek dental care. User also stated that she hit her forehead, has rug burn on her face, nose, and forehead and that her glasses were broken. The device remains with the user for her continued use. This report relates to independence technology complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16091510]
Service was dispatched to inspect the device and retrieve the electronic configuration file (ecf) for eval. 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 user has not reported any recurrence of the described event since the completion of the service activity. The ecf was evaluated for the reported event and the results were sent to the chu for inclusion in complaint records. The ecf and the associated "black box" data did not indicate a device malfunction or other fault condition. Data indicates that the device attempted to maintain / regain balance following a pitch disturbance or constraint, and that the device then auto-transitioned (per design) to 4-wheel function. The device then went to a fail-safe condition (per design) when conditions became too dynamic to maintain stability in 4-wheel function. The data do not corroborate/support the user's report that the device was lightly pushed/tapped, but indicates that the device had become constrained/stuck on an object or was interfered with by an external force.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2010-00005 |
| MDR Report Key | 1894877 |
| Report Source | 04 |
| Date Received | 2010-11-05 |
| Date of Report | 2010-11-05 |
| Date of Event | 2010-10-22 |
| Date Mfgr Received | 2010-10-26 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2012-03-13 |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NOT APPLICABLE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2010-11-05 |
| Model Number | IBOT |
| Catalog Number | IT004701 |
| Lot Number | NOT APPLICABLE |
| ID Number | NOT APPLICABLE |
| 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. Other; 2. Required No Informationntervention | 2010-11-05 |