MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-07-14 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004708 manufactured by Independence Technology, Llc.
[20925763]
A user reported that the ucp joystick became stuck in the left direction while operating the device in standard function. The user stated that this caused him to strike a light post, and that his foot was caught between the light post and the caster wheel of the device. The user reported that he sustained a cracked fibula as a result of the event, and that the ankle bone has been splinted. The user reported that there was no damage to the device, and that he was not wearing the provided lap belt at the time of the event. This report of a stuck joystick. This report corresponds to independence technology (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21206779]
A customer replaceable (cru) ucp assembly was send to the user on (b)(6) 2009. The reportedly discrepant part was received back at the service depot on (b)(6) 2009 and an evaluation was completed the same day. The initial evaluation did not determine any fault with the returned ucp assembly, and the users report of a stuck joystick could not be confirmed. The suspect ucp assembly was forwarded to development engineering for further review and investigation. That review also failed to confirm the reported event, and an internal examination of the joystick components did not reveal any abnormal operation and/or physical evidence (i. E. Excessive wear or witness marks) of the condition reported by the user. Minor assembly anomalies were noted during the engineering evaluation. These anomalies did not cause or contribute to the reported event, and will be addressed with the supplier of the ucp assembly through the supplier management program. All service depot and development engineering evaluations and outcomes are documented in the applicable complaint file for the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2009-00004 |
| MDR Report Key | 1416265 |
| Report Source | 04 |
| Date Received | 2009-07-14 |
| Date of Report | 2009-07-14 |
| Date of Event | 2009-06-28 |
| Date Mfgr Received | 2009-06-29 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2010-08-07 |
| 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 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 | RL |
| 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 | 2009-07-14 |
| Returned To Mfg | 2009-07-07 |
| Model Number | NA |
| Catalog Number | IT004708 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, LLC |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-07-14 |