OXYGENATOR, CARDIOPULMONARY BYPASS SET W/ QUADROX OPEN/CLOSED 70106.5907

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-30 for OXYGENATOR, CARDIOPULMONARY BYPASS SET W/ QUADROX OPEN/CLOSED 70106.5907 manufactured by .

MAUDE Entry Details

Report Number8010762-2019-00377
MDR Report Key9392253
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-11-30
Date of Report2019-11-28
Date of Event2019-11-12
Date Mfgr Received2019-11-12
Date Added to Maude2019-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetMAQUET CARDIOPULMONARY AG KEHLER STRASSE 31
Manufacturer CityRASTATT 76437
Manufacturer CountryGM
Manufacturer Postal76437
Manufacturer Phone4972229321
Manufacturer G1NURSEL BOELENS
Manufacturer StreetMAQUET CARDIOPULMONARY AG KEHLER STRASSE 31
Manufacturer CityRASTATT 76437
Manufacturer CountryGM
Manufacturer Postal Code76437
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOXYGENATOR, CARDIOPULMONARY BYPASS
Generic NameOXYGENATOR, CARDIOPULMONARY BYPASS
Product CodeDTZ
Date Received2019-11-30
Model NumberSET W/ QUADROX OPEN/CLOSED
Catalog Number70106.5907
Lot Number70129356
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

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