MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-08-26 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004061 manufactured by Independence Technology, L.l.c..
[932045]
User reported a lateral fall in the device in 4-wheel function. User stated that he was making a right turn and struck some bricks, causing the device to fall over sideways. User stated that he was not wearing the provided lap belt and fell from the device. User stated no major harm or injury, but he tore out his colostomy bag as a result of the event and will require a hospital visit. No device malfunction is indicated from this event. The user struck an object while operating the device, which caused the device to fall laterally. This mdr is filed due to the reported need for a hosp visit. (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[8107333]
As a result of the reported lateral fall, the device posted an audible and visual warning, and by design, operating functions were restricted to standard function. A service code was also posted on the device, per design. The customer service center (csc) retrieved a remote service code from the device and confirmed by review that the code was consistent with the customer's description of the event. As permitted by procedure, the csc cleared the code remotely, which returned the device to normal operating conditions and restored access to all available functionality.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00006 |
| MDR Report Key | 1137994 |
| Report Source | 04 |
| Date Received | 2008-08-26 |
| Date of Report | 2008-08-22 |
| Date of Event | 2008-08-17 |
| Date Mfgr Received | 2008-08-17 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2010-04-16 |
| 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 | US RT 22 WEST |
| 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 | 2008-08-26 |
| Model Number | NA |
| Catalog Number | IT004061 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | SOMERVILLE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2008-08-26 |