TERUMO CDI 100 MONITOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-20 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[2420903] During use of the device for a cardiopulmonary bypass procedure, the user reported that the monitor was not working correctly. The device was not changed out. The user reported the surgical procedure was completed successfully, and there were no delay or adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5


[9593286] Eval in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1828100-2012-00062
MDR Report Key2442616
Report Source06
Date Received2012-01-20
Date of Report2011-12-12
Date of Event2011-12-08
Date Mfgr Received2011-12-12
Date Added to Maude2012-08-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDOUGLAS FORTUNATO
Manufacturer Street6200 JACKSON RD.
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal48103
Manufacturer Phone7346634145
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTERUMO CDI 100 MONITOR
Product CodeDTY
Date Received2012-01-20
Returned To Mfg2012-01-10
Model Number100
Catalog Number100
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer AddressANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2012-01-20

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