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

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/22/2015

Event Type  malfunction  

Event Description

Patient was being raised in the lokomat by the winch and the winch automatically went downward.Stop button needed to be pushed.Patient was ambulating in the lokomat and error messages came on 4 times without any explanations.Treatment need to be stopped using the lokomat legs.Manufacturer response for exerciser, exerciser (per site reporter): unknown.

• 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: 5515914
• MDR Text Key: 40856424
• Report Number: 5515914
• 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
• 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: 8 YR
• Event Location: Outpatient Treatment Facility
• 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: 17 YR
• Patient Weight: 62