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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE/ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. SERIES T2100-ST2 TREADMILL; TREADMILL, POWERED
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GE HEALTHCARE/ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. SERIES T2100-ST2 TREADMILL; TREADMILL, POWERED Back to Search Results
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
¿ge is deploying stress test treadmill with known defect that causes treadmill to false start (treadmill belt moved about 1 inch and then halted).Vendor has provided workaround as there is no fix released at this time.Facilities are in need of firmware update asap as workaround is not a sufficient solution.Ge t2100-st2 is the affected model.¿.
 
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Brand Name
SERIES T2100-ST2 TREADMILL
Type of Device
TREADMILL, POWERED
Manufacturer (Section D)
GE HEALTHCARE/ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
MDR Report Key17886297
MDR Text Key325267480
Report NumberMW5146651
Device Sequence Number1
Product Code IOL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 10/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Patient Sequence Number1
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