T2100 TREADMILL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-29 for T2100 TREADMILL manufactured by General Electric Co..

MAUDE Entry Details

Report Number8835797
MDR Report Key8835797
Date Received2019-07-29
Date of Report2019-07-24
Date of Event2019-07-17
Report Date2019-07-24
Date Reported to FDA2019-07-24
Date Reported to Mfgr2019-07-29
Date Added to Maude2019-07-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameT2100 TREADMILL
Generic NameTREADMILL, POWERED
Product CodeIOL
Date Received2019-07-29
Model NumberT2100
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENERAL ELECTRIC CO.
Manufacturer Address465 PAN AMERICAN DR STE 11 EL PASO TX 79907 US 79907


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-29

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