MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-05-06 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004021 manufactured by Independence Technology, Llc.
[19531849]
User reported a fall down a set of five steps in standard function with the device, and that she fell from the device at the bottom of the steps. User stated that she had not intended to descend the steps, and that the device started rolling on its own. User initially reported injuries consisting of bumps, abrasions and contusions to her right knee, right shoulder, and a swollen/bruised left wrist. When asked if she was certain that the device made an uncommanded move, user replied that she "pretty sure", but that she was walking her dog on a leash at the time and that it was "possible the dogs leash hit the joystick, and caused the device to move but she doesn't think so". User was not wearing the provided lap belt at the time of the event. Via an online posting by the user, the company became aware that the user had also sustained an unreported impact to the back of the head, along with neck pain, and subsequently sought medical attention, the results of which were negative. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19716748]
Service was dispatched to retrieve the electronic configuration file (ecf) and inspect the device following the event. 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 event since the completion of the service activity. The ecf analysis indicated that the device had no alarms, no service wrench, and no black box data. This is normal for standard function. Indications are that the device was driven down the stairs in standard function. The user indicated that the wheel casters were stuck on a threshold when she was exiting a door, and that she pushed hard on the joystick to drive over the threshold. Once the casters overcame the obstacle, the device drove quickly forward and fell down the stairs. Engineering analysis suggests that this scenario is plausible, as the user created an increased torque when pushing the joystick forward with the wheels stuck. Based on known information about the event, there is no evidence of a device malfunction. As of 05/06/2009, the company has unsuccessfully attempted to contact the user to review findings and feedback on the circumstances of the event, and provide guidance on how to avoid recurrence when exiting the subject doorway.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2009-00002 |
| MDR Report Key | 1378311 |
| Report Source | 04 |
| Date Received | 2009-05-06 |
| Date of Report | 2009-05-06 |
| Date of Event | 2009-04-22 |
| Date Mfgr Received | 2009-04-22 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2010-08-07 |
| 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 | ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 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 | 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 | 2009-05-06 |
| Model Number | NA |
| Catalog Number | IT004021 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, LLC |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-06 |