ABL90 FLEX ANALYZER 393-090

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 2019-11-06 for ABL90 FLEX ANALYZER 393-090 manufactured by Radiometer Medical Aps.

MAUDE Entry Details

Report Number3002807968-2019-00053
MDR Report Key9283639
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-06
Date of Report2019-11-06
Date of Event2019-10-09
Date Mfgr Received2019-10-09
Device Manufacturer Date2010-10-19
Date Added to Maude2019-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. SOEREN MADSEN
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 NameABL90 FLEX ANALYZER
Generic NameABL90 FLEX ANALYZER
Product CodeCHL
Date Received2019-11-06
Returned To Mfg2019-11-01
Model Number393-090
Catalog Number393-090
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2019-11-06

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