MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-02-28 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, Llc..
[20687257]
An electrical smell after the device had been charging for 6-7 hours. User reported he looked at the device and there was smoke coming from the joystick of the user control panel (ucp). User reported, he looked at the battery charger and there were no light illiminated, at which time he unplugged the charger from the device and the wall outlet. User reported that the ucp was damaged. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003508375-2006-00001 |
| MDR Report Key | 685747 |
| Report Source | 04 |
| Date Received | 2006-02-28 |
| Date of Report | 2006-02-28 |
| Date of Event | 2006-02-01 |
| Date Mfgr Received | 2006-02-01 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-03-14 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL O'MEARA, DIRECTOR |
| Manufacturer Street | 45 TECHNOLOGY DRIVE |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084122200 |
| 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 | 2006-02-28 |
| Model Number | NA |
| Catalog Number | IT004051 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 674969 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, LLC. |
| Manufacturer Address | 45 TECHNOLOGY DR. WARREN NJ 07059 US |
| Baseline Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Baseline Generic Name | STAIR CLIMBING WHEELCHAIR |
| Baseline Model No | NA |
| Baseline Catalog No | IT004051 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-02-28 |