MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-03-23 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004710 manufactured by Independence Technology, L.l.c..
[1888301]
User reported that he sustained an injury (shoulder and back strain) and sought medical attention following a backwards fall while operating the device in standard function on a sidewalk late at night. User states that it was very dark out and he did not see a loose cable wire. User states that the cable wrapped around his right armrest and that the cable "closelined" the device causing the right armrest to break off. User also states that he felt the device tipping back when this occurred. User then powered device off. The device did fall backwards, but the user did not fall from the device. User states that he got out of the device and pushed the device back to an upright position, then got into the device and went home. User subsequently sought medical attention at (b)(6), where x-rays were taken and customer was given pain medication and muscle relaxers. Note: the "date of event" is approximate, as the user could not provide the exact date of the event, which was reported to the company on (b)(4) 2011. This report corresponds to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8996430]
The user stated that he would like to place an order for a seat assembly and a right armrest. The user was advised that there are no more seat assemblies of his style available and that a fold flat conversion would be required to resolve. User requested that a quote for the replacement/conversion be faxed to his attorney, which was completed on (b)(4) 2011. As of the date of this report, the user has not contacted the company to arrange for service to repair his device. In addition, as the event occurred when the device was in standard function, a service code was not generated (per design) and the device remains functional, though in need of repair. Retrieval of an electronic configuration file (ecf) would not benefit investigation of the event as the device was in standard function. Standard function is a non-dynamically stabilized function in which inertial data is not recorded. Consequently, field service has not yet been dispatched. Once field service occurs to repair the device, a field service activity/device functional check report (esar) will be forwarded to the complaint handling unit (chu) per standard operating procedure. Based on information provided by the user and the known circumstances of the event, there is no indication of a device malfunction, rather the event was precipitated by an external influence (cable wire) acting on the device. The device is not available for further evaluation at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2011-00003 |
| MDR Report Key | 2035821 |
| Report Source | 04 |
| Date Received | 2011-03-23 |
| Date of Report | 2011-03-23 |
| Date of Event | 2010-10-29 |
| Date Mfgr Received | 2011-03-15 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2012-06-05 |
| 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 | 2011-03-23 |
| Model Number | IBOT |
| Catalog Number | IT004710 |
| Lot Number | NOT APPLICABLE |
| ID Number | NOT APPLICABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-03-23 |