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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFOBIONIC, INC. MOME KARDIA; DETECTOR AND ALARM, ARRHYTHMIA
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INFOBIONIC, INC. MOME KARDIA; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number 01854
Device Problem Patient Data Problem (3197)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2021
Event Type  malfunction  
Event Description
This afternoon we were made aware of a technical issue at infobionic (heart rhythm device vendor), which caused a research study participant to be incorrectly diagnosed with atrial fibrillation.At the time of diagnosis, the patient and their physician were notified of the diagnosis.When one of the employees in the monitoring lab was finalizing the participant's report, they noticed the error and notified the pi and team.Infobionic has since resolved the technical issue and this situation will not occur again.The physician on the research study notified the patient and their physician of the situation.The participant did not receive any treatment and had not sought any care related to the false diagnosis.
 
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Brand Name
MOME KARDIA
Type of Device
DETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
INFOBIONIC, INC.
200 5th ave
4030
waltham MA 02451
MDR Report Key11222322
MDR Text Key241237199
Report Number11222322
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number01854
Device Catalogue Number01854
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2021
Device Age1 MO
Event Location Other
Date Report to Manufacturer01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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