MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-02-23 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004703 manufactured by Independence Technology, L.l.c..
[1422196]
User reported that on (b) (6) 2009, he was crossing the street in standard function when he was hit on the right side by a vehicle going approx 30-35 mph. User states that the device did not tip over from the impact, but just spun in circles. User reported that he sustained a broken right femur as a result of the impact, requiring surgery to implant a metal rod. User also states the police and ambulance personnel were unable to transport the device so he (user) went home to get his manual wheel chair and have his son then drive him to the hospital. User reported that he fell while transferring into his manual wheel chair from the ibot. At that time, his son decided to have an ambulance transport the user to hospital. The device reportedly sustained damage from the impact and service was dispatched to inspect the device and retrieve the ecf for review. (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[8442768]
Service was dispatched to inspect the device for damage and to retrieve the electronic configuration file (ecf) for review/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. The service engineer noted damage to both upper leg rest support side welds, front light assembly and two bulbs as a result of the event. Damaged parts were subsequently replaced and the device returned to service. The retrieved ecf was reviewed by engineering personnel. The device logs do not show any indication of a device malfunction or fault that would have caused or contributed to the reported event. A review of the product dhr was also conducted and showed no indication of any mfg issue that could have caused or contributed to the event. It is concluded that this is an adverse event and not a product malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2010-00001 |
| MDR Report Key | 1618155 |
| Report Source | 04 |
| Date Received | 2010-02-23 |
| Date of Report | 2010-02-18 |
| Date of Event | 2010-01-21 |
| Date Mfgr Received | 2010-02-02 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2010-03-05 |
| 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 SERVICE |
| Manufacturer Street | 7444 HAGGERTY RD |
| Manufacturer City | CANTON MI 48187 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48187 |
| Single Use | 3 |
| Remedial Action | IN |
| 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 | 2010-02-23 |
| Model Number | NA |
| Catalog Number | IT004703 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-02-23 |