FDA.reportPublic FDA data

MAUDE MDR 4647914

MDR report key
4647914
Report number
1218950-2015-01697
Event key
0
Event type
3
Date received
2015-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BETTY HARRIS
Address
3000 MINUTEMAN RD. ANDOVER MA 01810 US
Phone
978-978-9786
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEARTSTART MRXDEFIBRILLATORPHILIPS MEDICAL SYSTEMSMJKM3535AY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-270

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED AN ISSUE WITH RED X IN UPPER RIGHT HAND CORNER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

N

Patient 1

(B)(4).