TERUMO CDI 101 MONITOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-12-06 for TERUMO CDI 101 MONITOR manufactured by Terumo Cardiovascular System Corp..

Event Text Entries

[2453010] During preparation of the device for a cardiopulmonary bypass procedure, the user reported the monitor was showing erratic faults. There was a brief delay during preparation. The device was not changed out. The user reported the surgical procedure was completed successfully, and there were no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1828100-2011-03900
MDR Report Key2399311
Report Source01,07
Date Received2011-12-06
Date of Report2011-11-07
Date of Event2011-10-20
Date Mfgr Received2011-11-07
Date Added to Maude2012-07-20
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 101 MONITOR
Product CodeDTY
Date Received2011-12-06
Model Number101
Catalog Number101
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEM CORP.
Manufacturer AddressANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2011-12-06

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