MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-03-09 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004021 manufactured by Independence Technology, L.l.c..
[19002978]
Service was dispatched to inspect the device, clear the service wrench and retrieve the ecf log file for analysis. A report on field service activity (sar) and a device checkout record (fcr) was forwarded to the complaint handling unit (chu) per sop. Log file review determined the device entered cluster safety lock (going down stairs) and that, at the same time, it's pitch limit was exceeded. This is consistent with the assistants description of the event. Cluster safety lock (scl) is the devices detection of out of control stair climbing, and per user training, requires the user/assistant to respond appropriately to correct the condition(s) causing the csl. This did not occur in this case, leading to the event as reported. Follow up with the user's assistant indicated that "she probably just lost focus for a minute and didn't push down on the assist handle to slow the rotation". This is part of the trained/required technique for assisted stair climbing. Failure to perform the technique correctly can lead to the reported event. The company offered additional stair training to both parties, which was declined. Both parties understand that they can contact the company at any time for additional assistance or training. The user has not reported any recurrence of the described event since the completion of the service activity. It was also reported that both parties have resumed stair climbing activities without incident. No product malfunction occurred, and the device performed as expected for the given control inputs.
Patient Sequence No: 1, Text Type: N, H10
[19055049]
User's assistant (mother) reported a fall during assisted stair climbing. Caller stated that they got going too fast down steps and device went forward and hit the wall in front of her (stair turns). The user did not fall from the device, as she was wearing the provided lap belt. Consumer's face hit the wall and she received some bruising and scratches. Assistant also hit the wall and was injured with a bump on the head, some bruising on her face and a cut to the lip. Both parties report they are ok and do not require medical attention. During a follow up telephone call with the user's assistant, additional details were provided regarding the reported injuries. Further information also indicated that inattention to the assisted stair climbing procedure may have contributed to the event. While it was confirmed that a device malfunction did not occur, this report is filed due to the reported injuries to the user and assistant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003508375-2007-00002 |
| MDR Report Key | 826934 |
| Report Source | 04 |
| Date Received | 2007-03-09 |
| Date of Report | 2007-03-08 |
| Date of Event | 2007-02-13 |
| Date Mfgr Received | 2007-02-13 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2007-03-14 |
| 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 | 2007-03-09 |
| Model Number | NA |
| Catalog Number | IT004021 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 814329 |
| 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 | IT004021 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-09 |