ADVANCED PERFUSION SYSTEM 1 801188

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for ADVANCED PERFUSION SYSTEM 1 801188 manufactured by Terumo Cardiovascular Systems Corporation.

MAUDE Entry Details

Report Number1828100-2020-00147
MDR Report Key9908706
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-04-01
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-10-01
Date Added to Maude2020-03-31
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 ContactMR. DOUGLAS PATTON
Manufacturer Street6200 JACKSON ROAD
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal48103
Manufacturer Phone7346634145
Manufacturer G1SAME
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVANCED PERFUSION SYSTEM 1
Generic NameCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1
Product CodeDTQ
Date Received2020-03-31
Model Number801188
Catalog Number801188
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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