MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-06-30 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004061 manufactured by Independence Technology, L.l.c..
[907797]
User's wife reported a sideways fall of the device in 4-wheel function. Caller reported that the user sustained a shoulder injury and an ambulance was summoned to transport him to hospital for eval. Caller stated that her husband was operating the device in 4-wheel function in their yard. User was backing up and did not notice a bicycle in his path. The device attempted to climb over the bicycle, which lead to the reported sideways fall. The customer service center retrieved the remote service code from the device and confirmed controller failure, 4-wheel function, roll limit exceeded, which is consistent with the caller's description of the event. This report is filed as an adverse event mdr due to no product malfunction. This report corresponds to independence technology complaint.
Patient Sequence No: 1, Text Type: D, B5
[7888588]
Service was dispatched to retrieve the device electronic configuration file (ecf) for analysis. The analysis confirmed the earlier determination of no device malfunction. The customer service center called the user back. User states that he is in the healing process. The humorous bone in his shoulder was broken, and his arm is in a sling. User states that his dr... Expects that he will make a full recovery with no lasting side effects. User states that he is not disgruntled and realizes his error in backing into the bicycle. He explained that he drove into some landscaping rocks to look at a birdhouse. When he was done looking at it, he backed up the same way that he drove in. His son had dropped a bicycle directly behind him without him knowing it. The device climbed the bike, and then the bike tipped, causing the device to roll on its side. User said that it all happened very fast and did not allow him time to respond.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00004 |
| MDR Report Key | 1069844 |
| Report Source | 04 |
| Date Received | 2008-06-30 |
| Date of Report | 2008-06-27 |
| Date of Event | 2008-06-14 |
| Date Mfgr Received | 2008-06-14 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2009-05-04 |
| 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 | 45 TECHNOLOGY DR. |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084122200 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERVICE |
| Manufacturer Street | 7444 HAGGERTY RD. |
| 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 | CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2008-06-30 |
| Model Number | NA |
| Catalog Number | IT004061 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 45 TECHNOLOGY DR. WARREN NJ 07059 US 07059 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2008-06-30 |