ABL800 FLEX 393-800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-14 for ABL800 FLEX 393-800 manufactured by Radiometer Medical Aps.

MAUDE Entry Details

Report Number3002807968-2019-00048
MDR Report Key9185148
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-14
Date of Report2019-11-12
Date of Event2019-08-26
Date Mfgr Received2019-11-11
Device Manufacturer Date2006-06-07
Date Added to Maude2019-10-14
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 ContactMS CHRISTINE THISTED
Manufacturer StreetAAKANDEVEJ 21
Manufacturer CityBROENSHOEJ, 2700
Manufacturer CountryDA
Manufacturer Postal2700
Manufacturer G1RADIOMETER MEDICAL APS
Manufacturer StreetAAKANDEVEJ 21
Manufacturer CityBROENSHOEJ, 2700
Manufacturer CountryDA
Manufacturer Postal Code2700
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABL800 FLEX
Generic NameABL800 FLEX
Product CodeCHL
Date Received2019-10-14
Model Number393-800
Catalog Number393-800
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerRADIOMETER MEDICAL APS
Manufacturer AddressAAKANDEVEJ 21 BROENSHOEJ, 2700 DA 2700


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-14

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