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 05,06 report with the FDA on 2012-10-10 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[3069772] It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the monitor's battery was found to be leaking and battery failure occurred. As a result, an alternate device was employed and the suspect unit was taken out of service. The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the pt. There was no reported adverse event to the end user as well.
Patient Sequence No: 1, Text Type: D, B5


[10249901] The unit was taken out of service.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1828100-2012-01303
MDR Report Key2787490
Report Source05,06
Date Received2012-10-10
Date of Report2012-09-13
Date of Event2012-09-13
Date Mfgr Received2012-09-13
Device Manufacturer Date2002-05-01
Date Added to Maude2013-01-16
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 FDA0
Event Location0
Manufacturer ContactKIPP DURBIN
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 Received2012-10-10
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 2012-10-10

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