MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-10-09 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004021 manufactured by Independence Technology, Llc.
[707427]
While a another country field engineer (fe) was on site with the user in 2007, the user reported a fall from the device which occurred while stair climbing the previous month. The user sustained an injury to her elbow which required surgery. The user did not report the event to the company, even when she called a few weeks later for another technical issue. The user's boyfriend (assistant) was assisting her down the stairs in assisted stair climbing function, and experienced a cluster safety lock condition. The forward motion of the device was not corrected. The customer was not wearing the provided lap belt and fell out of the device and down the stairs. Based on a review of the device electronic configuration file (ecf), there was no product malfunction. This report corresponds to independence technology complaint.
Patient Sequence No: 1, Text Type: D, B5
[8116154]
The device ecf was retrieved for analysis once informed by the user of the fall in 2007. It was also subsequently confirmed with the user that the individual assisting her was not trained in the device's assisted stair climbing function. Analysis of the retrieved log file (ecf) indicates that the user's assistant did not properly control the device while descending the stairs in stair climbing function. Review indicates that a cluster safety lock condition was experienced during descent. The assistant did not sufficiently correct for forward pitch/momentum of the device during descent. The user was not wearing the provided lap belt, and it is believed that this contributed to falling from the device. Ecf review confirmed that the device did not fall, and there were no other faults in the product log that contributed to this event. The device logs are consistent with the owners description of the incident. After initiated a climb down a stair step, users and assistants are trained to control/slow the rate of the descent by moving the user's center of gravity rearward of the device rear wheels by leaning back in the seat while climbing down the step. It is the repetition of these actions that permits stair climbing with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2007-00006 |
| MDR Report Key | 925448 |
| Report Source | 04 |
| Date Received | 2007-10-09 |
| Date of Report | 2007-10-03 |
| Date of Event | 2007-08-05 |
| Date Mfgr Received | 2007-09-12 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2007-10-16 |
| 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 | 3 |
| 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 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 | 2007-10-09 |
| Model Number | NA |
| Catalog Number | IT004021 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 899186 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, LLC |
| Manufacturer Address | 45 TECHNOLOGY DRIVE WARREN NJ 07059 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-10-09 |