MAUDE MDR 1246346

MDR report key
1246346
Report number
3003508375-2008-00011
Event key
0
Event type
3
Date of event
2008-11-18
Date received
2008-11-26
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
ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone
908-908-9087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INDEPENDENCE IBOT 4000 MOBILITY SYSTEMSTAIR CLIMBING WHEELCHAIRINDEPENDENCE TECHNOLOGY, L.L.C.IMKNAIT004061NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-11-2601. H

Event Narratives#

D

Patient 1

USER'S SON REPORTED THAT HIS FATHER (USER) WAS DESCENDING STAIRS TO BASEMENT IN SOLO STAIR FUNCTION USING A HANDRAIL. IT WAS REPORTED THAT THE USER'S GRIP ON THE HANDRAIL SLIPPED, AND THE DEVICE AND USER FELL FORWARD. IT WAS REPORTED THAT THE DEVICE LANDED ON TOP OF THE USER. IT WAS UNKNOWN TO THE CALLER WHETHER THE PROVIDED LAP BELT WAS USED, OR NOT. THE USER APPEARS TO HAVE SUSTAINED A BROKEN LEFT LEG, BROKEN NOSE, AND WAS TRANSPORTED TO HOSPITAL BY AMBULANCE. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. REMOTE SERVICE CODES RETRIEVED FROM THE DEVICE INDICATE A CONTROLLER FAILURE IN STAIR FUNCTION, WITH THE PITCH LIMIT OF THE DEVICE BEING EXCEEDED, WHICH IS CONSISTENT WITH THE REPORTED FORWARD FALL. NO DEVICE MALFUNCTION IS INDICATED, AS MAINTENANCE OF A GRIP ON THE HANDRAIL WHILE SOLO STAIR CLIMBING IS REQUIRED TO PROPERLY EXECUTE THE STAIR CLIMBING FUNCTION AND MAINTAIN PROPER CONTROL OF THE DEVICE. THIS REPORT CORRESPONDS TO INDEPENDENCE TECHNOLOGY COMPLAINT.

N

Patient 1

SERVICE WAS DISPATCHED TO INSPECT THE DEVICE AND RETRIEVE A COPY OF THE ELECTRONIC CONFIGURATION FILE (ECF) FOR REVIEW. A REPORT ON FIELD SERVICE ACTIVITY / DEVICE CHECKOUT RECORD (ESAR) WAS FORWARDED TO THE COMPLAINT HANDLING UNIT (CHU) PER STANDARD OPERATING PROCEDURE. INSPECTION BY THE SERVICE REPRESENTATIVE NOTED SLIGHT DAMAGE AS A RESULT OF THE REPORTED EVENT, WHICH WAS CORRECTED, AND THAT THE DEVICE PASSED ALL FUNCTIONALITY CHECKS AND WAS APPROPRIATE FOR USE. ECF DATA REVIEW CONFIRMS THAT THE DEVICE WAS DESCENDING STAIRS IN STAIR FUNCTION WHEN A CLUSTER SAFETY LOCK WAS RECORDED. AT THE SAME TIMESTAMP, THE DEVICE WENT TO A CONTROLLER FAILURE CONDITION DUE TO ITS PITCH LIMIT BEING EXCEEDED. NO OTHER ALARMS WERE PRESENT IN THE LOGS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BLACK BOX DATA SHOWS THE DEVICE RELATIVELY IDLE ON A STEP FOR APPROX 9 SECONDS. THE USER THEN QUICKLY COMPLETES TWO SUCCESSIVE CLUSTER ROTATIONS WITH NO PAUSE BETWEEN. THE FIRST OF WHICH, THE DEVICE PITCH IS ADEQUATELY CORRECTED. AS THE SECOND CLUSTER ROTATION NEARS COMPLETION, THE USER DID NOT CORRECT THE DEVICE PITCH, AND THE DEVICE CONTINUED TO PITCH FORWARD. THE PRODUCT LOGS ARE CONSISTENT WITH THE CALLER'S DESCRIPTION OF THE EVENT. THE ABSENCE OF ANY PITCH CORRECTION ON THE 2ND STEP DESCENT IS INDICATIVE OF AN OPERATOR HAVING NO GRIP OR CONTROL OF THE DEVICE. ECF LOGS CONFIRMED THAT THE DEVICE DID NOT MALFUNCTION.