MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-01-04 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004041 manufactured by Independence Technology, Llc.
[21645278]
User reported that he sustained injuries to head, knees, shoulder, and a laceration to the nose following a forward fall in the device while descending two steps with a trained assistant. User states that he was at a graduation party and when leaving, he had to descend two steps in the device. User states that when he started to go down the first step the device made an unusual noise and pitched forward "throwing" the user out of the device. The user was not wearing the provided lap belt at the time of the event and landed on a cement slab, followed by the device. User was transported by ambulance to the emergency room. Medical personnel at the emergency room advised the user to follow up with primary care physician as necessary for knees, shoulders, head and face injury. No other injuries reported. User reports being sore with edema at injury sites. The customer service center (csc) noted that the user successfully negotiated ascending the same steps when arriving to the party. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21922143]
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 ecf review determined that the device entered stair function and a frame lean stop was recorded. Twelve seconds later the device recorded a controller alert indicating cluster safety lock (while descending). Within one second, the device reported going to a controller failure (cf) condition because of exceeding its pitch limit. No other alarms were present in the logs that would have contributed to this event. There is no indication of a device malfunction. 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. The service engineer noted on the esar that he did not notice any symptoms other than the cf code. The user has not reported any recurrence of the described event since the completion of the service activity. The csc followed up with the user regarding follow up doctor appointments. The user stated that he is healing up nicely and that his knee is slightly swollen and is not sure if he will be following up with a doctor in the future. The csc advised the user to follow up with the company if he does - user agreed to do so.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2011-00005 |
| MDR Report Key | 2418271 |
| Report Source | 04 |
| Date Received | 2012-01-04 |
| Date of Report | 2012-01-04 |
| Date of Event | 2011-12-13 |
| Date Mfgr Received | 2011-12-13 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2012-07-30 |
| 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 |
| 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 | 2012-01-04 |
| Model Number | IBOT |
| Catalog Number | IT004041 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Required No Informationntervention | 2012-01-04 |