MAUDE Adverse Event Report: HOCOMA AG LOKOMAT; SYSTEM, ISOKINETIC TESTING AND EVALUATION

Model Number LOKOMATPRO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Hematoma (1884); Skin Discoloration (2074); Discomfort (2330)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

At the moment no device failure could be identified.A user error (e.G.Neglecting contraindications, risk factors) cannot be excluded.Furthermore, we have hundreds of training sessions every day around the world and we never got similar feedbacks so far.Therefore, we assume that the specific patient-situation or the setting was not as intended according to the instruction for use.As this event is related to user's safety, hocoma decided to initiate this initial report.

Event Description

Patient reported discomfort to whole right leg during training.Therapist asked patient strap by strap if any of them were bothering her, to which she only responded yes to the upper thigh strap which the therapist loosened slightly.Therapist stopped treatment after 20 minutes even though the patient was wanting to continue.Upon inspection post treatment, patient had increased edema to the lower leg with discoloration that matched the area of the strap just below the knee as well as a knot just above where the ankle strap was.Patient subsequently transferred to acute care with a right lower extremity hematoma and had a couple of surgical procedures to evacuate hematomas.

Manufacturer Narrative

This is the final report of 3003781-2019-00002.Root cause analysis completed: the specific setting was not as intended according to the instruction for use.No device failure could be identified.Detected user error: - padding was not used to protect skin as indicated in the instruction of use.- risk factor: "skin lesions (including pressure sores) in areas of contact with harness support, robotic orthosis (buttocks and along lower extremities) or lower extremity loading (feet)" was neglected.As a re-training, the clinic again received a detailed description on how to do a proper set-up (hocoma knowledge platform entry "how can i protect patients' skin when they train on the lokomat?").

• Brand Name: LOKOMAT
• Type of Device: SYSTEM, ISOKINETIC TESTING AND EVALUATION
• Manufacturer (Section D): HOCOMA AG; industriestrasse 4b; volketswil, 8604 ; SZ 8604
• MDR Report Key: 9408675
• MDR Text Key: 169024759
• Report Number: 3003781275-2019-00002
• Device Sequence Number: 1
• Product Code: IKK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LOKOMATPRO
• Device Catalogue Number: 32001
• Device Lot Number: L60183
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 52