MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-06-30 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, L.l.c..
[899381]
User reported a forward fall with the device while descending outside steps. User states that he sustained an injury that required medical attention, but is ok now. User declined to provide further details on the extent of injury sustained. Event occurred last week - exact date was not provided. User was wearing the provided lap belt. User states he was being assisted by a (trained) assistant, who was also pulled down, sustaining contusions, but no other injury. The customer service center retrieved the remote service code and confirmed controller failure, stair function, pitch limit exceeded. Service is required to inspect device, clear service wrench and retrieve the device electronic configuration file for review. This report is filed as an adverse event mdr due to no product malfunction, and the users reluctance to provide details on the extent of any injury sustained. This report corresponds to independence technology (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[8069560]
Service was dispatched to retrieve the device electronic configuration file (ecf) for analysis. The analysis determined that the device entered stair function. Within 5 seconds, a frame lean stop was recorded. Forty one seconds later, the device recorded a controller alert indicating cluster safety lock (going down). One second later, the device went to a controller failure condition due to the pitch limit being exceeded. No other faults were present in the logs that contributed to this event. The black box data for the event shows the device completing the descent of one step successfully. The device is relatively idle for approximately 4 seconds, and then forward pitch induces a 2nd step descent. This is consistent with normal stair climbing procedure. The device pitch is not adequately corrected by the user's assistant. As the wheel cluster completes its rotation, the device pitch is released forward, inducing the cluster safety lock. The device continued to pitch forward until the limit was reached and the device went to controller failure. Based on the product logs, the product did not malfunction, and behaved as expected. The device entered cluster safety lock, and went to controller failure due to exceeding its pitch limit. Cluster safety lock is the devices detection of a loss of control during stair climbing. It is concluded that the assistant did not adequately control the device during stair descent, which lead to the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00005 |
| MDR Report Key | 1069843 |
| Report Source | 04 |
| Date Received | 2008-06-30 |
| Date of Report | 2008-06-27 |
| Date of Event | 2008-06-20 |
| Date Mfgr Received | 2008-06-20 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2010-04-12 |
| 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 | 2008-06-30 |
| Model Number | NA |
| Catalog Number | IT004051 |
| 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 | 45 TECHNOLOGY DR. WARREN NJ 07059 US 07059 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-30 |