PANDA IRES WARMER M1112198-039551

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-30 for PANDA IRES WARMER M1112198-039551 manufactured by Datex-ohmeda, Inc..

MAUDE Entry Details

Report Number2112667-2020-01074
MDR Report Key9899226
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2019-08-19
Date Mfgr Received2019-08-19
Device Manufacturer Date2011-06-15
Date Added to Maude2020-03-30
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 ContactDAVID WOODWORTH
Manufacturer Street3030 OHMEDA DRIVE
Manufacturer CityMADISON WI
Manufacturer CountryUS
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberSEEH10
Event Type3
Type of Report3

Device Details

Brand NamePANDA IRES WARMER
Generic NameWARMER, INFANT RADIANT
Product CodeFMT
Date Received2020-03-30
Model NumberM1112198-039551
Lot NumberHDJQ51331
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDATEX-OHMEDA, INC.
Manufacturer Address3030 OHMEDA DR, MADISON, WI 53718 US 53718


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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