HEMOSPHERE INSTRUMENT HEM1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-23 for HEMOSPHERE INSTRUMENT HEM1 manufactured by Edwards Lifesciences.

MAUDE Entry Details

Report Number2015691-2020-10260
MDR Report Key9623175
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-23
Date of Report2020-01-09
Date of Event2019-09-18
Date Mfgr Received2020-01-09
Device Manufacturer Date2019-06-14
Date Added to Maude2020-01-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS LYNN THOMAS
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9497564386
Manufacturer G1EDWARDS LIFESCIENCES
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMOSPHERE INSTRUMENT
Generic NameHEMOSPHERE INSTRUMENT (HEM1)
Product CodeDQK
Date Received2020-01-23
Model NumberHEM1
Catalog NumberHEM1
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-23

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