FDA.reportPublic FDA data

MAUDE MDR 8379772

MDR report key
8379772
Report number
3030677-2019-00421
Event key
0
Event type
3
Date received
2019-02-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MISS SHANNON DECKER
Address
22100 BOTHELL-EVERETT HWY BLDG A BOTHELL WA 98021 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEARTSTART HOMEAEDPHILIPS MEDICAL SYSTEMSNSAM5068AN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-280

Event Narratives#

N

Patient 1

D

Patient 1

IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.

N

Patient 1

.