CURITY 9570E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-31 for CURITY 9570E manufactured by Kendall Gammatron, Thailand.

Event Text Entries

[187560199] This product is not sold in us and is 510(k) exempt. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187560200] According to the reporter, the device was used on intubation but the ventilator showed no tidal volume. The device was replaced immediately and found to have leaked.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040459-2020-00023
MDR Report Key9908666
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-07-01
Date Added to Maude2020-03-31
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 FDA3
Event Location3
Manufacturer ContactAVI KLUGER
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306582
Manufacturer G1KENDALL GAMMATRON, THAILAND
Manufacturer StreetNAKHON CHAI SI DISTRICT
Manufacturer CityNAKHON PATHOM
Manufacturer CountryTH
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCURITY
Generic NameTUBE, TRACHEAL (W/WO CONNECTOR)
Product CodeBTR
Date Received2020-03-31
Model Number9570E
Catalog Number9570E
Lot Number1918209FED
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerKENDALL GAMMATRON, THAILAND
Manufacturer AddressNAKHON CHAI SI DISTRICT NAKHON PATHOM TH


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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