MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-04-07 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, Llc..
[19957705]
A user reported a forward fall in the device while being assisted to descend a set of stairs in assisted stair climbing function. The reported fall resulted in a broken nose that required medical attention. The user stated that instead of leaning backward during the descent, he leaned forward, which caused the device to fall forward and down the steps on top of him. No product malfunction is indicated. This report corresponds to independence technology complaint.
Patient Sequence No: 1, Text Type: D, B5
[20116733]
In either solo or assisted stair climbing function, users are an active component of the stair climb function, and are trained to lean in the correct direction in order to facilitate the completion of the ascent or descent. Service was dispatched to retrieve the electronic configuration file (ecf) in 2008. A report on field service activity (sar) and a device checkout record (fcr) will be forwarded to the complaint handling unit (chu) per standard operating procedure. Company review of the ecf confirms that the pitch of the device was in the forward direction, and with additional forward pitch, the cluster rotated. The device pitch was adequately corrected to slow the rotation, however, as the cluster rotation completed, the device was aggressively pitched forward again, most likely due to the forward lean described by the user. Device immediately entered cluster safety lock and continued to pitch forward. The assistant did not respond properly by preventing the device from continuing to pitch forward. Cluster safety lock is the device's response to an out of control stair climbing condition. 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 | 3003508375-2008-00002 |
| MDR Report Key | 1026099 |
| Report Source | 04 |
| Date Received | 2008-04-07 |
| Date of Report | 2008-03-31 |
| Date of Event | 2008-03-20 |
| Date Mfgr Received | 2008-03-20 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2009-05-01 |
| 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 | 45 TECHNOLOGY DRIVE |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084122200 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERVICE |
| 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 | 2008-04-07 |
| Model Number | NA |
| Catalog Number | IT004051 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, LLC. |
| Manufacturer Address | 45 TECHNOLOGY DRIVE WARREN NJ 07059 US 07059 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-04-07 |