MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-05-29 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004709 manufactured by Independence Technology, L.l.c..
[4685739]
User reported a fall of and from the device while operating outside in balance function. User stated that he sustained an abrasion to the forehead. User stated that he was in balance function in the yard and ran into a stake. The device auto-transitioned to 4-wheel function and he fell out of the device onto the grass. User stated that the device fell on top of him. User stated that he was not wearing the provided lap belt at the time of the event. User stated that he was on his stomach on the grass for about 10 mins before he was able to get someone's attention. An attendant was able to lift the device off the user and summon ems. User stated that he was not injured other than a scrape on his forehead and that he was not going to seek medical attention. The csc advised the user to transfer out of the device and then assisted with powering the device off. User was instructed not to power the device back on until field svc could visit to inspect it. Although no device malfunction is indicated, this mdr is being filed due to the potential for injury as a result of the unique sequence of events associated with event if it was to recur. Independence technology internal (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12162487]
Service was dispatched to inspect the device, retrieve the electronic configuration file (ecf) for eval, and clear the svc wrench. A field svc activity/device checkout report (esar) 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 svc activity. The ecf review determined that the device entered balance function on (b)(6) 2014, at 16:06:58 gmt and was operated for 3 mins 25 seconds before recording a controller alert indicating an auto-transition due to loss of traction. Within 2 seconds, the device went to a controller failure condition because the roll limit was exceeded. There were no other alarms present in the logs that would have contributed to this event. The black box data for the event confirms that while driving in balance function the device experienced a roll of a few degrees, during which both sides showed significant loss of wheel traction. This induced the controller alert and auto-transition. As a wheel clusters rotated the top wheels to the ground, the device rolled to the side and the 60 degrees limit was exceeded. In conclusion, the product did not malfunction and behaved as expected. The product does not have dynamic lateral stabilization. Environmental and dynamic driving conditions both can contribute to the device rolling laterally. The date is consistent with the user's report of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2014-00001 |
| MDR Report Key | 3855610 |
| Report Source | 04 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-29 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-05-16 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2014-06-24 |
| 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 W |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9087223767 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SVS |
| Manufacturer Street | 7444 HAGGERTY RD |
| 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 | 2014-05-29 |
| Model Number | IBOT |
| Catalog Number | IT004709 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2014-05-29 |