MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-01-09 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004706 manufactured by Independence Technology, Llc..
[1018284]
A user reported a forward fall of the device while descending 3 outdoor, carpeted steps in assisted stair function. User reported that he hit his head on the floor and sustained a broken nose and injury that required sutures. User reported that he was wearing the provided lap belt at the time of the event. Initial evaluation by service hotline personnel indicated a forward fall of the device, as a result of a possible cluster safety lock condition while descending stairs. User was advised that based on the reported circumstances, a field service visit would be required to inspect the device and retrieve the electronic configuration file (ecf) for evaluation. User stated that he would call back to schedule service following receipt of medical attention. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8203656]
Service was dispatched to inspect the device and retrieve the ecf for evaluation. A report on field service activity (sar) and a device checkout record (fcr) was forwarded to the complaint handling unit (chu) per standard operating procedure. Ecf review determined that the device entered stair function and a frame lean stop was recorded. Eighteen seconds later, the device recorded an alert indicating cluster safety lock (going down). Within 1 second, the device went to a controller failure condition due to its pitch limit being exceeded. No further alarms were present in the logs that would have contributed to this event. The black box data for this event was not available. Analysis determined that the device did not malfunction, and behaved as expected for the given inputs. The device entered cluster safety lock, and went to controller failure, due to exceeding its pitch limit. Cluster safety lock is the device's detection of a loss of control during stair climbing. No device malfunction is indicated. Further review of the user's event history indicated (3) events within 4 hours on the same date. The user was contacted by company personnel and offered additional stair climbing training, which was accepted, and has been scheduled for (b)(6) 2009. The complaint file will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2009-00001 |
| MDR Report Key | 1297468 |
| Report Source | 04 |
| Date Received | 2009-01-09 |
| Date of Report | 2009-01-09 |
| Date of Event | 2008-12-27 |
| Date Mfgr Received | 2008-12-27 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2010-07-13 |
| 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, DIR. |
| 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 RD. |
| 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 | 2009-01-09 |
| Model Number | NA |
| Catalog Number | IT004706 |
| 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, LLC. |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-01-09 |