FDA.reportPublic FDA data

MAUDE MDR 9908531

MDR report key
9908531
Report number
2021710-2020-11719
Event key
0
Event type
3
Date of event
2020-02-24
Date received
2020-03-31
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
MS. MINDY FABER
Address
26125 N. RIVERWOODS BLVD. METTAWA, IL US
Phone
757-757-7570
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VELA VENTILATORVENTILATOR, CONTINUOUS, FACILITY USEVYAIRE MEDICALCBKVELA16532-00N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

No narrative records found.