CARDIOHELP-I 70104.8012

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 2019-11-30 for CARDIOHELP-I 70104.8012 manufactured by Maquet Cardiopulmonary Gmbh.

MAUDE Entry Details

Report Number8010762-2019-00381
MDR Report Key9392252
Report SourceCONSUMER,FOREIGN,HEALTH PROFE
Date Received2019-11-30
Date of Report2019-11-29
Date of Event2019-10-20
Date Mfgr Received2019-10-21
Device Manufacturer Date2010-09-15
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 NameCARDIOHELP-I
Generic NameCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Product CodeDTQ
Date Received2019-11-30
Model NumberCARDIOHELP-I
Catalog Number70104.8012
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-11-30

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