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 07 report with the FDA on 2015-03-05 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[5628416] The service repair technician (srt) reported that during routine testing of the device at the service center, the battery was cracked in the blood parameter monitor (bpm). There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


[13049183] The reported complaint was confirmed. The battery is damaged and has leaked internal fluid into the unit. The product has been moved to the service department for disposition and will be scrapped. If additional information become available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1828100-2015-00147
MDR Report Key4597349
Report Source07
Date Received2015-03-05
Date of Report2015-02-10
Date Mfgr Received2015-02-10
Date Added to Maude2015-04-16
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 ContactJAN WINDER
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
Generic NameCDI 100
Product CodeDTY
Date Received2015-03-05
Returned To Mfg2015-01-26
Model Number100
Catalog Number100
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORP.
Manufacturer AddressANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-05

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