MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-07-24 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004000 manufactured by Independence Technology, L.l.c..
[678582]
Users mother reported that the battery charger made a loud "popping sound" during the middle of an overnight charge period, and that this was followed by a "burning electrical smell". It was reported that the battery charger is no longer functional, but that the ibot mobility system is fully charged and operating as expected. There was no allegation of harm reported by the user. While no injury was reported as a result of this event, if this event were to recur, there is a potential to cause injury to the user and/or damage to the device. This report corresponds to independence technology.
Patient Sequence No: 1, Text Type: D, B5
[7981358]
Note that the ibot mobility system was not returned for eval, only the associated battery charger. The battery charger was evaluated upon return and confirmed to be non-functional. The battery charger was forwarded to engineering for investigation after being returned. Upon review, the battery charger was determined to be inoperative. Internal examination did not reveal any visual or physical evidence of damage to support the reported "burning electrical smell". Engineering could not further troubleshoot the battery charger at this point. The root cause of the reported condition is not yet known. The battery charger was being returned to the mfr for further failure analysis and report. The results of the mfr's investigation are pending receipt. The results of the initial engineering review has been forwarded to the chu for inclusion in complaint records. The mfr's report and any identified further actions will also be forwarded to the chu once complete/known. The user has not reported any recurrence of the described event since the replacement of the battery charger. Please see add'l scanned pages.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2007-00008 |
| MDR Report Key | 886245 |
| Report Source | 04 |
| Date Received | 2007-07-24 |
| Date of Report | 2006-11-20 |
| Date of Event | 2006-10-23 |
| Date Mfgr Received | 2006-10-23 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2007-08-23 |
| 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, DIR |
| 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 | 2007-07-24 |
| Returned To Mfg | 2006-10-26 |
| Model Number | NA |
| Catalog Number | IT004000 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 864230 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | 45 TECHNOLOGY DR. WARREN NJ 07059 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-24 |