MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-09-18 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, L.l.c..
[21610704]
User reported a fall in the device. User reported that she was injured when her device tipped forward while descending a 9-10 inch high step in assisted stair climbing function, using a trained assistant. User reported that she struck her face, breaking her nose. The user was transported by ambulance to hospital for treatment of her injury. The assistant sustained a contusion in the event that did not require medical attention. The user was out of hospital and at home when she reported the event, and stated that she was feeling ok. The user was unable to tell if the event was caused by the device or the assistant - stated the device just fell forward and the assistant was unable to hold it. The service hotline additionally noted that based on the user's information, the device was operated outside of approved labeling for step height in stair function, which is labeled for 5-8 inches. This report corresponds to independence technology complaint.
Patient Sequence No: 1, Text Type: D, B5
[21820293]
Service was dispatched to inspect the device and retrieve the electronic log file for analysis. 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. 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. At the same time, the device went to a controller failure condition due to it's pitch limit being exceeded. There were no other faults in the product log that contributed to this event. A 9-10 inch step height is outside of the specification for step height documented in the device labeling. The device logs are consistent with the owners description of the incident. After initiating a climb down a stair step, users and assistants are trained to control/slow the rate of 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 climbings with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2007-00005 |
| MDR Report Key | 918056 |
| Report Source | 04 |
| Date Received | 2007-09-18 |
| Date of Report | 2007-09-17 |
| Date of Event | 2007-09-02 |
| Date Mfgr Received | 2007-09-03 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2007-11-15 |
| 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 | 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 | 2007-09-18 |
| Model Number | NA |
| Catalog Number | IT004051 |
| 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 | 902598 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | 45 TECHNOLOGY DRIVE WARREN NJ 07059 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-09-18 |