FDA.reportPublic FDA data

MAUDE MDR 9391958

MDR report key
9391958
Report number
2021710-2019-11073
Event key
0
Event type
3
Date of event
2019-11-12
Date received
2019-11-29
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
1VELA VENTILATORVENTILATOR, CONTINUOUS, FACILITY USEVYAIRE MEDICALCBKVELA16532-02N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-290

Event Narratives#

No narrative records found.