I BOT WHEELCHAIR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-21 for I BOT WHEELCHAIR manufactured by Johnson & Johnson Independence Tech..

Event Text Entries

[3058146] To whom it may concern: on friday, (b)(6) 2012, at approximately 5:10pm my ibot wheelchair suffered a catastrophic failure while i was using it. I was in the living room of my house in the balance mode when it began to beep, the on buttons was flashing red, and it showed a symbol i had never seen before. I now know that the symbol was indicating a complete system shutdown. Within 3 seconds of the start of the beeping the chair fell over backward causing me to hit my head hard on the rough surface of a ramp which the chair fell against. Had the chair been 6" forward, my head would have come done on a sharp corner of a 1/16" thick aluminum rail on the edge of the ramp, probably causing severe injury or possible death. The chair hit the floor with such force that the foot rests folded up above the level of the seat. I was shaken by the incident, and saturday morning i had a very sore neck from the fall. About 6:00pm friday night, i called your tech services and spoke to a lady named (b)(4). She was most helpful and got me calmed down while she took information. After several phone calls back to me, we mutually agreed that a service technician would come to my home on monday, (b)(6) to download the readings on the chair and try to get it off the floor. For fear of losing data that may be important in the future, i agreed no one would touch or move the chair until the technician completed his analysis. My wife took pictures immediately after the incident for documentation. On monday the 1(b)(6) the service technician downloaded the data and told me that there was no indication what caused the failure. When he picked the chair up off the floor we found a 1" cut in the head rest where it fell against the corner of the 1/16" railing. I believe this is a major safety failure of a licensed medical device that could have caused serious injury or death. I am very concerned about the safety of other users. I personally will never use the chair again in any mode other than the standard mode, which negates almost all of the usability of the chair for me. I will be contacting my attorney in the next two weeks to explore possible legal action and remedies.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5028412
MDR Report Key2896935
Date Received2012-12-21
Date of Event2012-12-14
Date Added to Maude2013-01-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameI BOT WHEELCHAIR
Generic NameWHEELCHAIR
Product CodeIMK
Date Received2012-12-21
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON INDEPENDENCE TECH.
Manufacturer Address45 TECHNOLOGY DRIVE WARREN NJ 07059 US 07059


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-21

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