FDA.reportPublic FDA data

MAUDE MDR 926113

MDR report key
926113
Report number
3003508375-2007-00007
Event key
0
Event type
3
Date of event
2007-10-01
Date received
2007-10-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MICHAEL O'MEARA, DIRECTOR
Address
45 TECHNOLOGY DR. WARREN NJ 07059 US
Phone
908-908-9084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INDEPENDENCE IBOT 4000 MOBILITY SYSTEMSTAIR CLIMBING WHEELCHAIRINDEPENDENCE TECHNOLOGY, LLCIMKNAIT004001NYN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-10-1001. O

Event Narratives#

D

Patient 1

A USER REPORTED TO A COMPANY PRODUCT CONSULTANT THAT HE EXPERIENCED A FALL FROM THE DEVICE WHILE DESCENDING STAIRS WITH AN ASSISTANT. THE USER REPORTED TO THE PC THAT FROM THE LAST STEP TO THE LANDING, THE ASSISTANT DID NOT SLOW THE DEVICE'S ROTATION, AND IT BOUNCED HARD ON THE LANDING. THE USER WAS NOT WEARING THE PROVIDED LAP BELT AND FELL FROM THE DEVICE ONTO THE LANDING. IT WAS REPORTED THAT THE USER BRUISED HIS KNEE AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT TIP OR FALL OVER, AND NO FAULTS OR SERVICE CODES WERE POSTED. A COMPANY REPRESENTATIVE FOLLOWED UP WITH THE USER AND CONFIRMED THE REPORTED EVENT. THE USER REPORTED THAT AN X-RAY REVEALED A FRACTURE TO THE KNEE CAP AND HE WAS WEARING A SPLINT. NO SURGERY IS CURRENTLY SCHEDULED.

N

Patient 1

SERVICE WAS DISPATCHED TO INSPECT THE DEVICE AND RETRIEVE AN ELECTRONIC CONFIGURATION FILE (ECF). 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. THE USER HAS NOT REPORTED ANY RECURRENCE OF THE DESCRIBED EVENT SINCE THE COMPLETION OF THE SERVICE ACTIVITY. ALTHOUGH NO FAULTS WERE REPORTED WITH THE DEVICE, THE ECF WILL BE EVALUATED TO CONFIRM. THE RESULTS OF THIS REVIEW WILL BE FORWARDED TO THE CHU FOR INCLUSION IN COMPLAINT RECORDS.