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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REGULATORY INSIGHT, INC. LOKOMAT; SYSTEM, ISOKINETIC TESTING AND EVALUATION
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REGULATORY INSIGHT, INC. LOKOMAT; SYSTEM, ISOKINETIC TESTING AND EVALUATION Back to Search Results
Model Number LOKOMAT
Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2015
Event Type  malfunction  
Event Description
When attempting to increase treadmill speed from 1 to 1.1 mph on the lokomat, the legs increased speed disproportionately to the treadmill.Equipment was stopped.Restarted at 1.1 mph without problem, but after about 30 seconds the lokomat stopped and gave an error message about the sensor of the right hip.Manufacturer response for exerciser, exerciser (per site reporter): hocoma is scheduled to come for repair 11/11/2015.Will provide information regarding this new error.
 
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Brand Name
LOKOMAT
Type of Device
SYSTEM, ISOKINETIC TESTING AND EVALUATION
Manufacturer (Section D)
REGULATORY INSIGHT, INC.
33 golden eagle lane
littleton, CO 80127
MDR Report Key5515916
MDR Text Key40874737
Report Number5515916
Device Sequence Number1
Product Code IKK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2016
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberLOKOMAT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2016
Device Age8 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age9 YR
Patient Weight17
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