MEDFUSION 4000 4000-0101-51

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for MEDFUSION 4000 4000-0101-51 manufactured by Smiths Medical Asd, Inc..

MAUDE Entry Details

Report Number9391716
MDR Report Key9391716
Date Received2019-11-29
Date of Report2019-11-26
Date of Event2019-11-17
Report Date2019-11-26
Date Reported to FDA2019-11-26
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDFUSION 4000
Generic NamePUMP, INFUSION
Product CodeFRN
Date Received2019-11-29
Model Number4000-0101-51
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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