FDA.reportPublic FDA data

MAUDE MDR 9836524

MDR report key
9836524
Report number
1828100-2020-00127
Event key
0
Event type
3
Date of event
2020-02-20
Date received
2020-03-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DOUGLAS PATTON
Address
6200 JACKSON ROAD ANN ARBOR MI 48103 US
Phone
734-734-7346
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVANCED PERFUSION SYSTEM 1CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1TERUMO CARDIOVASCULAR SYSTEMS CORPORATIONDTQ802100802100N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-160

Event Narratives#

No narrative records found.