MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-05-13 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004061 manufactured by Independence Technology, L.l.c..
[19541793]
User reported an approximate 15 ft fall with the device from a wooden deck on to a concrete patio below. User reported that he sustained a bump to the back of his head, along with some cuts to both the back of his head and forehead, and being sore as a result of the fall. User underwent a cat scan, with negative results for further head injury or internal bleeding. User stated that the event occurred when he attempted to transition from the device 4-wheel to balance function, while being close to the deck railing. As the device was transitioning, the assist handle became caught under the railing, breaking through the railing and resulting in the fall from the deck. Customer stated that the device landed on the rear wheels and then fell backwards. This report is filed as an adverse event mdr due to no product malfunction.
Patient Sequence No: 1, Text Type: D, B5
[19714634]
Svc was dispatched to inspect the device following the reported fall. A report on field svc activity and a device checkout record was forwarded to the complaint handling unit (chu) per standard operating procedure. The device was not returned to use by the svc engineer due to observed damage to the device that required repair. Return of the device for eval and final determination of needed repair(s) is expected, but has not occurred at the time of this report. The device will be evaluated once returned to the mfg. Location, and the results of this review will be forwarded to the chu for inclusion in complaint records.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00003 |
| MDR Report Key | 1047429 |
| Report Source | 04 |
| Date Received | 2008-05-13 |
| Date of Report | 2008-05-07 |
| Date of Event | 2008-04-23 |
| Date Mfgr Received | 2008-04-25 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2009-09-10 |
| 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 | 45 TECHNOLOGY DR. |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084122200 |
| 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 | 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 | 2008-05-13 |
| 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 | 2008-05-13 |