MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-02-09 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004061 manufactured by Independence Technology, L.l.c..
[20989586]
User called to request service stating that he tipped the device over twice while on vacation in europe. For 1st event, user reported that while descending a set of stairs with his wife's assistance, she pulled back and the device fell back on her. User would not discuss if his wife was injured - stated he did not care if information regarding injury was required for the investigation. For 2nd event, user reported that he has just finished climbing stairs and transitioned to balance function. User states the device fell over backwards. The user was not injured. While no injury was confirmed as a result of these events, this mdr is being filed due to the absence of confirmation of injury to the users wife, when the device reportedly fell back on her. This report corresponds to independence technology complaint # 782504 and 782793.
Patient Sequence No: 1, Text Type: D, B5
[21064668]
Service was dispatched to clear a service wrench in response to a call from a user. A report on field service activity (sar) and a device checkout record (fcr) was forwarded to the complaint handling unit (chu) per standard operating procedure. The user has not reported any recurrence of the described event. The ecf (electronic configuration file) was evaluated once returned to the mfg. For the 1st event, the ecf shows there is only 1 controller failure in the file, which occurred in 2006, at 07:28 gmt. This was for a pitch limit exceeded, which indicates the assistant pulled too far back on the device while descending the stairs. It is likely, while descending, the assistant accidentally pulled back too much when slowing down the rotation, and caused the device to climb back up one step, and her footing may have not been prepared for that. As the file was not retrieved until one month later, only this single alarm is available. In reference to the 2 events in the order stated by the consumer, the stair event could not have caused a service wrench, since the 2nd event mentions transition to balance, which would be disable if the first event caused a wrench. For the 2nd event, no other alarms occurred in 2006, prior to the pitch limit controller failure. Event data was not available. No device malfunction is indicated by the ecf review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2007-00001 |
| MDR Report Key | 820140 |
| Report Source | 04 |
| Date Received | 2007-02-09 |
| Date of Report | 2007-02-07 |
| Date of Event | 2007-01-09 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2007-02-27 |
| 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 | RP |
| 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 | 2007-02-09 |
| Model Number | NA |
| Catalog Number | IT004061 |
| 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 | 807610 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| 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 | IT004061 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-09 |