FDA.reportPublic FDA data

MAUDE MDR 9889280

MDR report key
9889280
Report number
3008642652-2020-02635
Event key
0
Event type
3
Date of event
2020-03-05
Date received
2020-03-27
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
ANNA BEATTY
Address
121 GAMMA DRIVE PITTSBURGH, PA US
Phone
968-968-9683
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIFEVEST WCD 4000 SYSTEMWEARABLE CARDIOVERTER DEFIBRILLATORZOLL MANUFACTURING CORPORATIONMVKWCD 400010A0988Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2701. O; 2. R

Event Narratives#

No narrative records found.