MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-11-26 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004061 manufactured by Independence Technology, L.l.c..
[973762]
User's son reported that his father (user) was descending stairs to basement in solo stair function using a handrail. It was reported that the user's grip on the handrail slipped, and the device and user fell forward. It was reported that the device landed on top of the user. It was unknown to the caller whether the provided lap belt was used, or not. The user appears to have sustained a broken left leg, broken nose, and was transported to hospital by ambulance. No further information is known at this time. Remote service codes retrieved from the device indicate a controller failure in stair function, with the pitch limit of the device being exceeded, which is consistent with the reported forward fall. No device malfunction is indicated, as maintenance of a grip on the handrail while solo stair climbing is required to properly execute the stair climbing function and maintain proper control of the device. This report corresponds to independence technology complaint.
Patient Sequence No: 1, Text Type: D, B5
[8250556]
Service was dispatched to inspect the device and retrieve a copy of the electronic configuration file (ecf) for review. A report on field service activity / device checkout record (esar) was forwarded to the complaint handling unit (chu) per standard operating procedure. Inspection by the service representative noted slight damage as a result of the reported event, which was corrected, and that the device passed all functionality checks and was appropriate for use. Ecf data review confirms that the device was descending stairs in stair function when a cluster safety lock was recorded. At the same timestamp, the device went to a controller failure condition due to its pitch limit being exceeded. No other alarms were present in the logs that would have contributed to this event. Black box data shows the device relatively idle on a step for approx 9 seconds. The user then quickly completes two successive cluster rotations with no pause between. The first of which, the device pitch is adequately corrected. As the second cluster rotation nears completion, the user did not correct the device pitch, and the device continued to pitch forward. The product logs are consistent with the caller's description of the event. The absence of any pitch correction on the 2nd step descent is indicative of an operator having no grip or control of the device. Ecf logs confirmed that the device did not malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00011 |
| MDR Report Key | 1246346 |
| Report Source | 04 |
| Date Received | 2008-11-26 |
| Date of Report | 2008-11-25 |
| Date of Event | 2008-11-18 |
| Date Mfgr Received | 2008-11-18 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2009-01-26 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2008-11-26 |
| Model Number | NA |
| Catalog Number | IT004061 |
| Lot Number | NA |
| ID Number | NA |
| 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. Hospitalization | 2008-11-26 |