MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC Q-STRESS; TREADMILL, POWERED

Device Problem Unintended Movement (3026)

Patient Problems Abrasion (1689); Fall (1848)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

Patient was exercising on a treadmill during a stress echocadiogram.The patient exercised 10 minutes and 30 seconds.The nurse told the patient that she was going to stop the treadmill and instructed the patient to lie down quickly once the treadmill stopped.The nurse clicked the "stop belt" icon on the screen.The belt paused momentarily and the patient attempted to lie down.The nurse was assisting the patient onto the table when the belt started to accelerate.The patient lost his balance and fell onto the moving treadmill belt.The patient fell onto his right elbow.The nurse also fell at this point in an effort to avoid patient injury.The sonographer hit the two red "stop" buttons on the keyboard.The treadmill belt stopped.The patient was attempting to get up when the belt started to accelerate again.The patient then hit his neck on the treadmill belt.The sonographer then hit the emergency stop button which completely stopped the treadmill belt from moving.The patient was then assisted onto the table by the nurse and sonographer.I was then notified of this event and went into the exam room to assist.I asked the cardiology fellow to come into the stress room to assess the patient.The patient had several abrasions located on his right lower back, hip, right elbow and right neck.The cardiology fellow contacted the attending cardiologist who recommended that we bring the patient to the ed for further assessment.We monitored the patient for approximately 15 minutes post event and then transported him to the ed via wheelchair.

• Brand Name: Q-STRESS
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): MORTARA INSTRUMENT, INC; 7865 north 86th street; milwaukee WI 53224
• MDR Report Key: 4226042
• MDR Text Key: 21942398
• Report Number: 4226042
• Device Sequence Number: 1
• Product Code: IOL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR