MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-09-17 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, L.l.c..
[956536]
It was reported that a user's assistant lost control of the device while descending stairs in assisted stair function. The device itself did not fall, however, the user was not wearing the provided lap belt and fell forward from the device. It was initially reported that the user sustained a bump to the head and a facial laceration. Follow up with the user's assistant confirmed that an emergency room visit had determined that the user had additionally sustained a broken nose and a fractured optical bone, that reportedly will require surgery to repair. (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[8237939]
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 rep determined that the device passed all functionality checks and was appropriate for use. Based on information available, the device did not malfunction. The event resulted from failure of the assistant to properly control the device while descending stairs in assisted stair function, and the user's failure to wear the provided lap belt, as recommended in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00008 |
| MDR Report Key | 1165265 |
| Report Source | 04 |
| Date Received | 2008-09-17 |
| Date of Report | 2008-09-15 |
| Date of Event | 2008-09-10 |
| Date Mfgr Received | 2008-09-10 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2010-06-12 |
| 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 | 2008-09-17 |
| Model Number | NA |
| Catalog Number | IT004051 |
| 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 | 2008-09-17 |