MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-10-10 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004001 manufactured by Independence Technology, Llc.
[720744]
A user reported to a company product consultant that he experienced a fall from the device while descending stairs with an assistant. The user reported to the pc that from the last step to the landing, the assistant did not slow the device's rotation, and it bounced hard on the landing. The user was not wearing the provided lap belt and fell from the device onto the landing. It was reported that the user bruised his knee as a result of this event. It was also reported that the device did not tip or fall over, and no faults or service codes were posted. A company representative followed up with the user and confirmed the reported event. The user reported that an x-ray revealed a fracture to the knee cap and he was wearing a splint. No surgery is currently scheduled.
Patient Sequence No: 1, Text Type: D, B5
[7860361]
Service was dispatched to inspect the device and retrieve an electronic configuration file (ecf). A report on field service activity (sar) and a device checkout record (fcr) were forwarded to the complaint handling unit (chu) per standard operating procedure. The user has not reported any recurrence of the described event since the completion of the service activity. Although no faults were reported with the device, the ecf will be evaluated to confirm. The results of this review will be forwarded to the chu for inclusion in complaint records.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2007-00007 |
| MDR Report Key | 926113 |
| Report Source | 04 |
| Date Received | 2007-10-10 |
| Date of Report | 2007-10-09 |
| Date of Event | 2007-10-01 |
| Date Mfgr Received | 2007-10-01 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2007-12-06 |
| 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 | 45 TECHNOLOGY DR. |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084122200 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERVICES |
| Manufacturer Street | 7444 HAGGERTY RD |
| 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 | 2007-10-10 |
| Model Number | NA |
| Catalog Number | IT004001 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 915560 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, LLC |
| Manufacturer Address | 45 TECHNOLOGY DR. WARREN NJ 07059 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-10 |