MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-25 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004708 manufactured by Independence Technology, L.l.c..
[1254410]
User reported that he sustained a contusion to his left shoulder when he fell forward approx. 16 steps with the device while descending stadium style stairs in solo stair function. User reported that the device started to fall forward, then turned to the side, ending up on its left side, which is the same side as the reported shoulder contusion. User went to the er to be evaluated. Outcome of x-ray was negative for fracture / other injury, except for reported contusion, for which orders were given to ice shoulder for 24 hours and warm massages thereafter. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8321833]
Per normal procedure, the customer support center (csc) retrieved the remote service code from the device with the assistance of the user, to troubleshoot the reported event and help determine if a malfunction may have occurred. The retrieved code indicated that the pitch limit of the device had been exceeded while in stair function. This is consistent with the reported event. No other indications of a fault or device malfunction were detected. The reported event is consistent with improper or incorrect technique while stair climbing. In stair function, the user is an integral component of the function and must maintain control of the device in order to negotiate stairs. The csc also reminded the user to be aware of step height and depth when stair climbing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2009-00010 |
| MDR Report Key | 1553732 |
| Report Source | 04 |
| Date Received | 2009-11-25 |
| Date of Report | 2009-11-24 |
| Date of Event | 2009-11-20 |
| Date Mfgr Received | 2009-11-20 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2010-09-29 |
| 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 W |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9087223767 |
| 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 | 2009-11-25 |
| Model Number | NA |
| Catalog Number | IT004708 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Other | 2009-11-25 |