MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-09-22 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT04000 manufactured by Independence Technology, L.l.c..
[537079]
User reported that he was descending a flight of stairs, the device locked up and fell forward on the 2nd step down. User reported the device fell forward down the stairs with him in it. The user stated that his shoulder was sore and he visited the er the next day for examination and x-ray. User stated he was experiencing pain and his shoulder was swollen. No further information was available or subsequently provided by the user regarding the reported injury. This report corresponds to independence technology complaint # 746475.
Patient Sequence No: 1, Text Type: D, B5
[7805095]
Service was dispatched to inspect the device, clear the service wrench that was generated as a result of the event, and to retrieve the device electronic configuration file (ecf) for review and 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 analysis of the ecf determined that the device entered a cluster safety lock condition during stair climbing. Cluster safety lock temporarily restricts movement of the wheel clusters in response to a detected issue with user inputs (control) during stair climbing. Cluster safety lock is the designed device response to out of control stair climbing. Based on the ecf analysis, the device did not malfunction, but responded to the detected out of control condition. Users are trained on the proper response to this condition, which is to wait and allow the device to return to a neutral position on the stairs, at which time the cluster safety lock with automatically resolve and permit continued climbing. Based on the evidence available, it appears the user did not properly respond to the cluster safety lock and did not follow the correct procedure in this case. The user has not reported any recurrence of the described event since the completion of the service activity. The results of this review were forwarded to the chu for inclusion in complaint records.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2006-00005 |
| MDR Report Key | 767852 |
| Report Source | 04 |
| Date Received | 2006-09-22 |
| Date of Report | 2006-09-15 |
| Date of Event | 2006-08-24 |
| Date Mfgr Received | 2006-08-24 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2006-10-11 |
| 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 | 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 | 2006-09-22 |
| Model Number | NA |
| Catalog Number | IT04000 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 755742 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | 45 TECHNOLOGY DR. WARREN NJ 07059 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-22 |