TERUMO CDI 100 MONITOR 5330

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 2013-07-03 for TERUMO CDI 100 MONITOR 5330 manufactured by Terumo Cardiovascular Systems Corp..

Event Text Entries

[20699510] It was reported by the customer that the battery was cracked on the blood parameter monitor (bpm). This was a backup battery and was found while walking by the battery sitting on a charger. This was not pertaining to any case or setup, and there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


[21005136] The reported issue was confirmed by visual inspection. Corrosion was evident on the battery where it was exposed. This product is being phased out in the global market. Service and replacement parts are no longer available. If additional information becomes 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 Number1828100-2013-00689
MDR Report Key3214221
Report Source05,06
Date Received2013-07-03
Date of Report2013-06-11
Date of Event2013-06-11
Date Mfgr Received2013-06-11
Date Added to Maude2013-08-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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
Product CodeDTY
Date Received2013-07-03
Returned To Mfg2013-06-27
Model Number5330
Catalog Number5330
OperatorHEALTH PROFESSIONAL
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 2013-07-03

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