MAUDE Adverse Event Report: REGULATORY INSIGHT, INC. LOKOMAT; SYSTEM, ISOKINETIC TESTING AND EVALUATION

Model Number LOKOMAT PRO

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2015

Event Type  malfunction  

Event Description

Patient was removed from the equipment, and hocoma support was contacted.Support walked writer through a calibration process.The patient was again set up in the lokomat, and gait training was initiated.Within 5 min of starting training, the lokomat pc alerted the user that it was "rebooting now".The machine shut down with the patient on the treadmill within the robotic system.The two above listed witnesses were called to assist with removal of the patient from the system.The manual/emergency release of the overhead harness system was initiated, but it required the addition of writer's weight on the hanger/pulley in order to lower the patient to his wheelchair.The system would not lower completely to the wheelchair seat, but dismount was able to be achieved with the use of the seat elevator function on the patient's wheelchair.The lokomat system could not be restarted on this day.
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manufacturer response for exerciser, exerciser (per site reporter)
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unknown.Company is aware of ongoing issues.

• 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 Key: 5515915
• MDR Text Key: 40856368
• Report Number: 5515915
• Device Sequence Number: 1
• Product Code: IKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 03/22/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LOKOMAT PRO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2016
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2016
• 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 Number: 1
• Patient Age: 28 YR
• Patient Weight: 79