MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CASE; TREADMILL, POWERED

Model Number TREADMILL

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Injury (2348)

Event Date 06/14/2019

Event Type  malfunction  

Event Description

In total, there were 6 incidents involving 4 different ge case machines.It was recorded that two of these incidents caused in the abrupt stoppage of the treadmill track, one of which resulted in patient injury.The remaining events included the ge case machines slowly coming to a complete stop.Following these incidents, the treadmills were unable to be used.After these events, many parts were replaced by ge in attempt to fix the issue including printed circuit board processor, elevation potentiometer, limit switches, acquisition module board, motherboard and hard drive.Some issues found were fixed by replacing these components.It is unknown what is causing these issues and the investigation remains ongoing.

• Brand Name: CASE
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 9151523
• MDR Text Key: 161101989
• Report Number: 9151523
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2019,09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TREADMILL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/03/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other