LOKOMAT NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for LOKOMAT NA manufactured by Regulatory Insight, Inc..

Event Text Entries

[40874736]
Patient Sequence No: 1, Text Type: N, H10

[40874737] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5515916
• MDR Report Key: 5515916
• Date Received: 2016-03-22
• Date of Report: 2016-02-15
• Date of Event: 2015-11-09
• Report Date: 2016-02-15
• Date Reported to FDA: 2016-02-15
• Date Reported to Mfgr: 2016-02-15
• Date Added to Maude: 2016-03-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LOKOMAT
• Generic Name: SYSTEM, ISOKINETIC TESTING AND EVALUATION
• Product Code: IKK
• Date Received: 2016-03-22
• Model Number: LOKOMAT
• Catalog Number: NA
• Lot Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: 8 YR
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: REGULATORY INSIGHT, INC.
• Manufacturer Address: 33 GOLDEN EAGLE LANE LITTLETON, CO 80127 US 80127

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-03-22