KIT, RAD-97 PULSE CO-OXIMETER 25892 9738

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-10-18 for KIT, RAD-97 PULSE CO-OXIMETER 25892 9738 manufactured by Masimo - 52 Discovery.

MAUDE Entry Details

Report Number3011353843-2019-00096
MDR Report Key9210715
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-10-18
Date of Report2019-09-26
Date of Event2001-01-01
Date Mfgr Received2019-09-26
Device Manufacturer Date2017-09-20
Date Added to Maude2019-10-18
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 ContactSTEFAN LISSMANN
Manufacturer Street52 DISCOVERY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9492977168
Manufacturer G1MASIMO - MEXICALI
Manufacturer StreetINDUSTRIAL VALLERA DE MEXICALI CALZADA DEL ORO, NO.2001
Manufacturer CityMEXICALI, BAJA CALIFORNIA 21600
Manufacturer CountryMX
Manufacturer Postal Code21600
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKIT, RAD-97 PULSE CO-OXIMETER
Generic NameOXIMETER
Product CodeMWI
Date Received2019-10-18
Model Number25892
Catalog Number9738
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMASIMO - 52 DISCOVERY
Manufacturer Address52 DISCOVERY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-18

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