MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-10-28 for INDPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, L.l.c..
[21627333]
User stated that the device lap belt created a pressure sore on her abdomen. User stated that the lap belt is very tight and becomes so immediately after buckling it. User stated that her previous lap belt did not have this issue. The user stated that a nurse attended to her for two (2) weeks to provide wound care, and that she is not currently using the lap belt in order to prevent further injury. This report corresponds to independence technology complaint.
Patient Sequence No: 1, Text Type: D, B5
[21818663]
Service was dispatched to inspect the device for lap belt functionality. A report on field service activity (sar) and a device checkout record (fcr) were forwarded to the complaint handling unit (chu) per standard operating procedure. Service by the customer engineer (ce) involved verifying that armrests, seat pan, and assist handle were level. The ce noted that the seat back was slanted to the left when the device was viewed from the front, and that the headrest was not level. The functional check record (fcr) completed by the ce as part of service activities indicated that the device passed all functionality checks and was appropriate for use. Upon further review, it was determined that the seat assy. Would be replaced and the returned seat (incl. Lap belt) would be evaluated to determine if the observed condition could have contributed to the reported event. Seat replacement was completed in 2008, but the replaced seat assy. Is still in transit back to the manufacturer for evaluation. Once completed, the result of the evaluation will be included in the complaint record. While no malfunction was observed by the ce, this mdr is filed as any contributory factor(s) regarding the observed condition to the reported injury is not known at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00010 |
| MDR Report Key | 1215494 |
| Report Source | 04 |
| Date Received | 2008-10-28 |
| Date of Report | 2008-10-28 |
| Date of Event | 2008-09-29 |
| Date Mfgr Received | 2008-09-29 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-06-16 |
| 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 | ROUT E22 WEST |
| Manufacturer City | SOMMERVILLE 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2008-10-28 |
| Model Number | NA |
| Catalog Number | IT004051 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2008-10-28 |