PANDA IRES WARMER

MAUDE Adverse Event Report

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

MAUDE Entry Details

Report Number2112667-2020-01066
MDR Report Key9897555
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2017-01-23
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 ContactJASON KELLY
Manufacturer Street3000 N GRANDVIEW BLVD.
Manufacturer CityWAUKESHA 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
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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