MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-03-01 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004710 manufactured by Independence Technology, Llc.
[1935818]
On (b)(6) 2011, a user reported that he sustained an injury (bad contusion) to his left arm when he was struck by an automobile while operating the device in balance function in a parking lot. The user stated that the event occurred on (b)(6) 2010. User stated that "he was seeing doctors and lawyers and he did not have time to report it until now. " user stated that he was in balance function going straight across a parking lot when an automobile made a right hand turn and hit him broadside on the right side of the device, causing the device to transition from balance to 4-wheel function. User stated that the automobile did not stop and continued to push him several feet into a boardwalk. The impact of the device into the boardwalk caused his left arm to be pinned up against the armrest as the armrest was bent into him from the boardwalk. The user stated that "this incident was not caused by the device and if the device were not so well built, may have been killed or injured much more badly. " this report corresponds to independence technology complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8831357]
The user called on (b)(6) 2011 to request a quotation to repair his device, and reported the (b)(6) 2010 event during that contact with the company. Engineering review of an electronic configuration file (ecf) covering the time period of the reported event was subsequently conducted in an attempt to either substantiate or refute the user's account of the event. Engineering personnel determined that there were no relevant entries in the alarm logs for that date and that there was nothing relevant to the event in the ecf for the month of (b)(6) 2010. The ecf review substantiates the user's account and it is concluded that there was no device malfunction associated with the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2011-00002 |
| MDR Report Key | 2013061 |
| Report Source | 04 |
| Date Received | 2011-03-01 |
| Date of Report | 2011-03-01 |
| Date of Event | 2010-10-26 |
| Date Mfgr Received | 2011-02-24 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2012-05-23 |
| 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 | 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 | 2011-03-01 |
| Model Number | IBOT |
| Catalog Number | IT004710 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-03-01 |