MAUDE MDR 797455

MDR report key
797455
Report number
1720406-2006-00001
Event key
0
Event type
3
Date of event
2006-11-27
Date received
2006-12-09
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
JEANENNE PHILLIPS
Address
4335 S. SANTA FE. DR. ENGLEWOOD CO 80110 US
Phone
303-303-3037
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUPERARMVAN LIFT FOR THE DISABLEDHANDICAPS, INC.ING2000ENANANRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-12-0901. H

Event Narratives#

D

Patient 1

FULL NARRATIVE REPORT AVAILABLE BY REQUEST; CONTACT JEANENNE, 303-781-2062. PATIENT'S ASSISTANT WAS LOADING PATIENT ON LIFT SYSTEM. ASSISTANT REACHED OVER THE LIFT AND PLACED HERSELF BETWEEN LIFT AND ROOF OF THE VAN. SOME CLOTHING OR OTHER ITEM CAUGHT ON THE OPERATION SWITCH AND PINNED HERSELF BETWEEN THE LIFT AND THE ROOF OF THE VAN "SQUISHING" HER. SAFETY SYSTEM DID OPERATE SINCE SHE WAS NOT CRUSHED. SHE WAS ABLE TO HIT THE EMERGENCY OVERRIDE, BUT SINCE WHAT EVER WAS DEPRESSING THE TOGGLE WAS NOT REMOVED, THE LIFT JUST CHATTERED, AND "ACTED CRAZY". SHE WAS AIDED BY OTHERS WHO FREED HER AND "TORE THE LIFT APART". SHE WAS TAKEN BY AMBULANCE TO THE HOSPITAL WHERE SHE WAS SEEN AND RELEASED. DIAGNOSIS ACCORDING TO THE ASSISTANT WAS BACK SPASMS AND SHE WAS REFERRED TO A CHIROPRACTOR FOR FURTHER FOLLOW UP. USER'S FATHER IS PURCHASING A NEW UNIT FOR THE USER. AFTER SPEAKING WITH HIM, HE SAYS THAT HE IS NOT SURE IF HE WANTS TO MAKE THE LIFT AVAILABLE FOR FACTORY RETURN, AND WILL HAVE TO THINK ON THAT. FOLLOW UP IS BEING PURSUED BY HANDICAPS, INC, THE MANUFACTURER.

N

Patient 1

EVENT IS STILL IN THE PROCESS OF INVESTIGATION. CORRECTIVE AND PREVENTATIVE TEAM IS MEETING TO DETERMINE CORRECT ACTION. WE ARE CONTINUING IN COMMUNICATION WITH THE CLIENT'S FAMILY TO REACH RESOLUTION. THE MANUFACTURER BELIEVES THAT THIS ADVERSE EVENT TOOK PLACE BECAUSE OF IMPROPER USE, INADEQUATE TRAINING TO THE ASSISTANT. THE LIFT MOTOR POSSESSES SUFFICIENT STRENGTH TO KNOCK OUT A CLOSED DOOR, OR CRUSH BONES AND POTENTIALLY CAUSE DEATH IF USED IMPROPERLY. IT IS FOR THAT REASON THAT THE ELECTRIC EYE SAFETIES ARE PUT IN PLACE. IT IS HANDICAPS' OPINION THAT THE SAFETY SYSTEM PREFORMED IT'S FUNCTION, ALTHOUGH IT CAUSED DISCOMFORT THE LIFT ARM STOPPED BEFORE IT CAUSED SERIOUS INJURY OR DEATH. PREVENTATIVE AND CORRECTIVE TEAM IS WORKING ON RELABELING AND ADDITIONAL TRAINING PROGRAMS FOR DEALERS AND END USERS.