VITAL SIGNS? CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN WITH GA M1152225

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-10 for VITAL SIGNS? CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN WITH GA M1152225 manufactured by Vyaire Medical.

MAUDE Entry Details

Report Number3004050971-2019-00003
MDR Report Key9176743
Date Received2019-10-10
Date of Report2019-08-29
Date of Event2019-08-28
Date Mfgr Received2019-11-18
Date Added to Maude2019-10-10
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 ContactSTANLEY TAN
Manufacturer Street22745 SAVI RANCH PKWY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer Phone7149193324
Manufacturer G1VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD
Manufacturer Street45-46 SHABU INDUSTRIAL ZONE QIAO LONG DISTRICT, TANGXIA
Manufacturer CityDONGGUAN, 523730
Manufacturer CountryCH
Manufacturer Postal Code523730
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITAL SIGNS? CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN WITH GA
Generic NameCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Product CodeCAI
Date Received2019-10-10
Model NumberBREATHING CIRCUIT
Catalog NumberM1152225
Lot Number182633
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-10

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