FDA.reportPublic FDA data

MAUDE MDR 8658084

MDR report key
8658084
Report number
2021710-2019-10307
Event key
0
Event type
3
Date of event
2019-05-02
Date received
2019-05-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STANLEY TAN
Address
22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AVEA VENTILATORVENTILATOR, CONTINUOUS, FACILITY USEVYAIRE MEDICALCBKAVEA17311-00Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-310

Event Narratives#

N

Patient 1

A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE GAS DELIVERY ENGINE (GDE) WAS REMOVED AND THE RIBBON CABLES WERE RESEATED. THE FSR COULD NOT CONFIRM THE PROBLEM REPORTED WITH THE INACCURATE FIO2 VALUES. THE DEVICE WAS TESTED AND THE FIELD SERVICE REP CONFIRMED IT PASSED ALL TESTING AND MET ALL VYAIRE MANUFACTURER SPECIFICATIONS.

D

Patient 1

IT WAS REPORTED TO VYAIRE THAT THEY FIO2 WAS INACCURATE AND WAS NOT ABLE TO BE CORRECTED.