MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GE CASE STRESS TEST; TREADMILL, POWERED

Model Number CASE SERIES 2012492

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2021

Event Type  Injury  

Event Description

Patient was on treadmill during stress test.Treadmill unit did start as expected and when it finally did (about 1 minute after the start button was pressed) it elevated and started at a high speed.The stop button on the console did not halt the unit and the patient had to be caught by the attending physician; 2 hospital employees were in the room at this time and witnessed the event.Summary of the issues- unit started at high speed unexpectedly; units did stop when the red stop button was pressed.Fda safety report id# (b)(4).

• Brand Name: GE CASE STRESS TEST
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• MDR Report Key: 11731546
• MDR Text Key: 247710430
• Report Number: MW5100992
• Device Sequence Number: 1
• Product Code: IOL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CASE SERIES 2012492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR