MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-03-01 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004011 manufactured by Independence Technology, L.l.c..
[2552203]
User reported a forward fall of the device while attempting to descend a set of exterior cement stairs in stair function. No injury was reported. User states that he had a previous injury (pulled muscle in arm) and while holding onto the railing to descend steps, because of his arm injury, he was unable to lean back properly/enough to keep the device from rotating its wheel cluster, and the chair moved out from underneath him and proceeded to descend the stairs on its own. The device fell to the ground, while user was still holding onto the railing. User states that the device sustained no damage, other than a scuff mark on the back of the armrest. User was not injured, and he had assistance getting back into and using the device. User was advised by service hotline that the event may have occurred quickly and not allowed proper exit from cluster safety lock, but also that the driver/assistant should have control of the device while in stair function. It was suggested to the user to perhaps have assistance with stair climbing while injured. Field service was dispatched to inspect the device, clear the service wrench and retrieve the electronic configuration file (ecf) for review. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9758953]
Service was dispatched to inspect the device, retrieve the electronic configuration file (ecf) for evaluation, and clear the service wrench. A field service activity/device checkout report (esar) was forwarded to the complaint handling unit (chu) per standard operating procedure. The engineering review of the ecf determined that on (b)(6) 2012 at 13:45:45 gmt, the device entered stair function and recorded a frame lean stop. Twenty six (26) seconds later, the device recorded a controller alert indicating a cluster safety lock condition while descending. At the same time stamp, the device went to a controller failure condition because of exceeding its pitch limit. No other alarms were present in the logs that would have contributed to this event. The black box data for the event shows that a one step descent was successfully completed with proper control. A second step is descended with inadequate pitch correction by the user, allowing for a rapid forward pitch of the device and cluster safety lock condition. The device then continued to pitch forward until the limit w as exceeded. The conclusion is that the device did not malfunction. The device entered cluster safety lock, and went to controller failure due to exceeding its pitch limit. Cluster safety lock is the devices detection of a loss of control during stair climbing and is consistent with the user's report of the circumstances of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2012-00001 |
| MDR Report Key | 2483433 |
| Report Source | 04 |
| Date Received | 2012-03-01 |
| Date of Report | 2012-03-01 |
| Date of Event | 2012-02-25 |
| Date Mfgr Received | 2012-02-27 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2012-08-01 |
| 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 | IN |
| 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 | 2012-03-01 |
| Model Number | IBOT |
| Catalog Number | IT004011 |
| 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, L.L.C. |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-01 |