RAD-97 W/NIBP 26245 9797

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 2019-09-27 for RAD-97 W/NIBP 26245 9797 manufactured by Masimo - 52 Discovery.

MAUDE Entry Details

Report Number3011353843-2019-00067
MDR Report Key9130474
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-09-27
Date of Report2019-09-10
Date of Event2019-09-01
Date Mfgr Received2019-09-30
Device Manufacturer Date2018-03-28
Date Added to Maude2019-09-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEFAN LISSMANN
Manufacturer Street52 DISCOVERY
Manufacturer CityIRVINE CA 926181604
Manufacturer CountryUS
Manufacturer Postal926181604
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 NameRAD-97 W/NIBP
Generic NameOXIMETER
Product CodeMWI
Date Received2019-09-27
Returned To Mfg2019-09-19
Model Number26245
Catalog Number9797
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMASIMO - 52 DISCOVERY
Manufacturer Address52 DISCOVERY IRVINE CA 926181604 US 926181604


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-27

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