MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-12-15 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004011 manufactured by Independence Technology, L.l.c..
[20346442]
User's father reported a problem with the ucp joystick sticking causing uncommanded motion forward. Caller states the rubber boot seems to slide under the housing causing the joystick to stick in a forward position. Caller states that the user was pinned against a wall while sitting on the floor as an assistant was guiding the device slowly toward him. The left caster wheel ran over the user's right leg and then hit the wall. Several assistants released the user by leaning the device back and pulling it away from him. At that time the wheels were not driving the device into the user, who was pinned for 2 to 3 seconds. Caller states the user was briefly short of breath with rib pain across front middle of chest for a few minutes and tenderness. Leg was tender and painful and user sustained a superficial cut on the end of his left arm at elbow where arm was previously amputated - treated with an adhesive dressing. No medical attention, but user's father is a doctor, and he reported no neck/back injury or abdominal pain noted in his examination.
Patient Sequence No: 1, Text Type: D, B5
[20402175]
Service was dispatched to retrieve the device electronic configuration file (ecf) for review. A report on field service activity (sar) and a device checkout record (fcr) is forwarded to the complaint handling unit (chu) per standard operating procedure. Ecf review found no indication of joystick/ucp failure. No events or alarms were present in the logs that would have contributed to the described event no fail-safe conditions occurred which would have triggered a black box snapshot. Evaluation of the event and alarm data, covering a six month time period in 2008, reveals no indication of a problem with ucp or joystick command. At this time, only a mechanical evaluation of the ucp could confirm/rule out the presence of the physical defect described in the complaint. The ucp is not available for evaluation as the user declined to pursue the non-warranty replacement of the assembly at this time. The user was advised not to use the device as the reported event could recur. The user and his father were advised that the ucp should be replaced. The user has not reported any recurrence of the described event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00012 |
| MDR Report Key | 1310889 |
| Report Source | 04 |
| Date Received | 2008-12-15 |
| Date of Report | 2008-12-05 |
| Date of Event | 2008-11-21 |
| Date Mfgr Received | 2008-11-21 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2009-09-29 |
| 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, DIRECTOR |
| 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 | 2008-12-15 |
| Model Number | NA |
| Catalog Number | IT004011 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-15 |