FDA.reportPublic FDA data

MAUDE MDR 9782689

MDR report key
9782689
Report number
3009715978-2020-00001
Event key
0
Event type
3
Date received
2020-03-03
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
MR. SAKET BHATT
Address
444 CASTRO STREET SUITE 600 MOUNTAIN VIEW, CA US
Phone
396-396-3968
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KARDIAMOBILEMOBILE ELECTROCARDIOGRAMALIVECOR, INC.DPSAC-009AC-009R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-030

Event Narratives#

N

Patient 1

ALIVECOR RECEIVED A COMPLAINT FROM USER'S RELATIVE WHERE IT APPEARS THAT THE USER WHILE EXPERIENCING A HEART ATTACK RECORDED AN ECG AND LIKELY RECEIVED DEVICE ALGORITHM ANALYSIS OF "NORMAL SINUS RHYTHM". IT IS UNKNOWN WHETHER THE USER DELAYED SEEKING MEDICAL ATTENTION DUE TO THE KARDIAMOBILE RESULT. ALIVECOR FOLLOWED UP WITH THE USER 4 SEPERATE TIMES TO GET ADDITIONAL INFORMATION BUT WAS NOT SUCCESSFUL. ALIVECOR IS A LEAD-I MOBILE ECG THAT IS NOT INTENDED TO DETECT HEART ATTACKS. THE DEVICE LABELING SPECIFIES THAT THE DEVICE DOES NOT DETECT HEART ATTACK. IT IS POSSIBLE FOR ECGS DURING A HEART ATTACK TO STILL BE NORMAL SINUS RHYTHM. IT APPEARS THAT THE DEVICE LIKELY HAD NO MALFUNCTION, DID NOT CAUSE OR CONTRIBUTE TO THE HEART ATTACK, AND THE INCIDENT WAS A RESULT OF USER ERROR.

D

Patient 1

PATIENT'S FAMILY MEMBER CONTACTED ALIVECOR STATING THAT THE PATIENT USED KARDIAMOBILE TO TAKE EKG AND RECEIVED NORMAL SINUS RHYTHM DETERMINATION WHILE EXPERIENCING A HEART ATTACK. THE SPECIFIC COMMENT FROM THE PATIENT'S FAMILY MEMBER NOTES THAT "...WE FOUND OUT IT (KARDIAMOBILE) WAS DEFECTIVE WHEN MY MOM USED THE PRODUCT AND IT SHOWED NORMAL AS SHE WAS IN THE MIDDLE OF A HEART ATTACK".