MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-04-09 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004011 manufactured by Independence Technology, L.l.c..
[3277395]
User's mother reported that user sustained a mild concussion, scratches on both arms that required bandaging, and a concussion above his right eye, not requiring sutures, following a sideways fall from the device in standard function. Caller reports that the device did not contact any surface or fall over. Caller states that the user was on a concrete deck outside. He leaned over the right armrest, when the bolt holding the armrest broke off and the user fell onto the concrete deck. User's father is a physician and stated that his son had a concussion. Caller states that the user was not wearing the provided lap belt at the time of the event as advised in accompanying device labeling. Caller states that there was no service code or service wrench posting on the device. Caller inquired about the armrest fastener specifications, which were provided. Caller states that user will repair his device. The caller was advised that there should be 2 bolts securing the armrest to the device. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10731608]
Service was dispatched to inspect the device and retrieve the electronic configuration file (ecp) for review. The customer engineer (ce) called while on site stating that the right armrest was damaged and needed to be replaced. Ce states that one of the screws that connected the armrest to the backrest had sheared off and the bracket was bent. The ce also states that the right front light assembly needed to be replaced. Ce advised the user that these parts need to be replaced and the user stated that he will contact the company when ready to purchase. Ce stated that he believed that the device fell over. Ce also reported that the batteries were no charged and was unable to retrieve the ecf. The fcr indicated that the device does not pass functionality checks and cannot be returned to service. A field service activity / device checkout report (esar) was forwarded to the complaint handling unit (chu) per standard operating procedures. Further attempts are being made to retrieve the ecf for review. However, based on the nature of the event, and as the device was in standard function, the ecf is not expected to contain any pertinent info. This report is being filed in advance of ecf retrieval and review, which, as of (b)(6) 2013, has been unsuccessful due to the user not returning telephone calls / messages requesting access to the device. However, if ecf retrieval is successful and contains any data relevant to this event, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2013-00001 |
| MDR Report Key | 3068066 |
| Report Source | 00 |
| Date Received | 2013-04-09 |
| Date of Report | 2013-04-09 |
| Date of Event | 2013-03-26 |
| Date Mfgr Received | 2013-03-26 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2013-04-30 |
| 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 | RT 22 W |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9087223767 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERVICES |
| Manufacturer Street | 7444 HAGGERTY RD |
| Manufacturer City | CANTON MI 48187 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48187 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2013-04-09 |
| Model Number | IBOT |
| Catalog Number | IT004011 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-04-09 |