JAEGER V-175420 175452-13

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 2019-07-31 for JAEGER V-175420 175452-13 manufactured by Vyaire Medical.

MAUDE Entry Details

Report Number9615102-2019-00107
MDR Report Key8847823
Report SourceFOREIGN,USER FACILITY
Date Received2019-07-31
Date of Report2019-07-01
Date of Event2019-07-01
Date Mfgr Received2019-07-01
Date Added to Maude2019-07-31
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 ContactMR. STANLEY TAN
Manufacturer Street510 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone7149193324
Manufacturer G1VYAIRE MEDICAL GMBH
Manufacturer StreetLEIBNIZSTRASSE 7
Manufacturer CityHOECHBERG, 97204
Manufacturer CountryGM
Manufacturer Postal Code97204
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJAEGER
Generic NameCALCULATOR, PULMONARY FUNCTION DATA
Product CodeBZC
Date Received2019-07-31
Model NumberV-175420
Catalog Number175452-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-31

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