HEART LUNG MACHINE 701028692 - HL 20 701028692

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2020-03-16 for HEART LUNG MACHINE 701028692 - HL 20 701028692 manufactured by Maquet Cardiopulmonary Gmbh.

MAUDE Entry Details

Report Number8010762-2020-00106
MDR Report Key9837612
Report SourceCONSUMER,FOREIGN,HEALTH PROFE
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-01-27
Date Mfgr Received2020-02-28
Device Manufacturer Date2018-02-19
Date Added to Maude2020-03-16
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 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 NameHEART LUNG MACHINE
Generic NameCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Product CodeDTQ
Date Received2020-03-16
Model Number701028692 - HL 20
Catalog Number701028692
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOPULMONARY GMBH
Manufacturer AddressNEUE ROTTENBURGER STRASSE 37 HECHINGEN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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