MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-09-08 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, L.l.c..
[920022]
Information about a possible user fall from the device was reported by sales management during a review of sales information. Information suggested that the user had fallen (possibility more than once) while maneuvering into his van. The user indicated in sales notes that the device tilts over and he falls to the street when backing into his vehicle. There is no evidence that the user called the service hotline to report the event. When contacted, the user stated that he had fallen once and that there were not multiple events. The user stated that the unreported event occurred on (b) (6) 2008. The user sought medical attention "a couple of days" after the event when his neck and arms started to hurt. An mri revealed no bone fractures. The user declined his physicians recommendation of physical therapy as he already has therapy once a week for his pre-existing medical condition. User stated that pain has reduced with time and his physician's opinion is that time is needed to heal. This report corresponds to independence technology complaint # (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[8199614]
Service was dispatched to inspect the device and retrieve the ecf for analysis. 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. Ecf data and device logs contain no event or alarm log entries that indicate a problem consistent with the user's description. There were no device log entries between (b) (6) 2008 and (b) (6) 2008. Review indicates that most likely, the user experienced a fall in the product while in a non-dynamically stabilized function, such as standard. As indicated in the user manual, standard function is intended to be used on slopes that are less than or equal to 5 degrees. There is no indication of product malfunction, and no product service codes were logged by the device during the event. The service hotline reviewed proper procedure for maneuvering into a vehicle by using unoccupied remote function as outlined in product labeling. This mdr is filed for the reported injury to the user. The user has not reported any recurrence of the described event since the completion of the service activity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00007 |
| MDR Report Key | 1157431 |
| Report Source | 04 |
| Date Received | 2008-09-08 |
| Date of Report | 2008-09-05 |
| Date of Event | 2008-07-28 |
| Date Mfgr Received | 2008-08-18 |
| Device Manufacturer Date | 2008-04-01 |
| 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 | 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 | 0987723767 |
| 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 | 2008-09-08 |
| Model Number | NA |
| Catalog Number | IT004051 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-08 |