MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-03-01 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004706 manufactured by Independence Technology, Llc.
[18956825]
Service was dispatched to inspect the device, retrieve the electronic configuration file (ecf) for evaluation, and clear the service wrench. A field service activity / device checkout report (esar) was forwarded to the complaint handling unit (chu) per standard operating procedure. The ecf was not retrieved until (b)(6) 2011 due to a delay by the user in making the device available for inspection. Therefore, only alarm log and black box data was available for review, as the event logs had been overwritten due to continued use of the device. Engineering review of the ecr determined that the device went to a controller failure condition due to the balance metric exceeding its limit, while in 4-wheel function. The black box data confirms the device was on a flat level surface and driven forward over an obstacle or step in 4-wheel function. As the cluster angle leveled, it over-rotated as both wheel motors spun up indicating loss of traction. At this time, the device went to controller failure due to exceeding the balance metric in 4-wheel function. The ecf is consistent with the report of loss of traction during a step ascent in 4-wheel function. The device went to failsafe and stopped logging data prior to the device falling backward as reported by the user. At the time of the failsafe, the device was pitched forward and tipped forward onto the front two wheels. It was concluded that the device did not malfunction and behaved as expected. The device went to failsafe when conditions became too dynamic to maintain stability in 4-wheel function.
Patient Sequence No: 1, Text Type: N, H10
[19101232]
User reported a backwards fall in her device while operating in 4-wheel function on (b)(6) 2011. User states that she was climbing a concrete step from a balcony into her apartment. User states that the device successfully climbed the step, but then fell backwards on the concrete balcony when the wheels slipped on the step that was wet from rain. User states that, based on a friends diagnosis, she believes that she sustained whiplash and a concussion, although no attention was sought from a medical professional. The csc attempted to troubleshoot the event with the user by remotely retrieving the service code from the device. However, the user was not with the device at the time of the call, therefore, an on-site service visit was set up for the service engineer to inspect the device, retrieve the electronic configuration file (ecf) for review, and clear the service wrench. This mdr is filed based on the user's unconfirmed allegation of injury. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003508375-2011-00001 |
| MDR Report Key | 2013074 |
| Report Source | 04 |
| Date Received | 2011-03-01 |
| Date of Report | 2011-03-01 |
| Date of Event | 2011-02-04 |
| Date Mfgr Received | 2011-02-09 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2012-05-24 |
| 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 | SOMMERVILLE 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 | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2011-03-01 |
| Model Number | IBOT |
| Catalog Number | IT004706 |
| 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 | SOMMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-01 |