MAUDE Adverse Event Report: REGULATORY INSIGHT, INC. (HOCOMA AG) LOKOMATPRO; SYSTEM, ISOKINETIC TESTING AND EVALUATION

Model Number LOKOMATPRO

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Event Description

When using lokomat, had patient in harness and strapped into orthotic.Attempted to start machine, and four error codes were generated.Attempted to restart, same error codes generated, requiring reboot of the machine.The patient was removed from the device, and unable to complete the treatment.No injury to the patient, no potential for injury to the patient.Prior to reboot, attempted to run the machine without a patient in it, and same error codes were generated.

• Brand Name: LOKOMATPRO
• Type of Device: SYSTEM, ISOKINETIC TESTING AND EVALUATION
• Manufacturer (Section D): REGULATORY INSIGHT, INC. (HOCOMA AG); 33 golden eagle lane; littleton CO 80127
• MDR Report Key: 5842672
• MDR Text Key: 51019243
• Report Number: 5842672
• 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: 07/20/2016,07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LOKOMATPRO
• 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: 07/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2016
• 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