MoMe® Kardia 01854Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B690MK10), received between Aug 11, 2020 and Feb 8, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2021Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method; Human-Device Interface Problem; Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method; Human-Device Interface Problem

  A PRODUCT MALFUNCTION EVENT WAS REPORTED BY HEALTHCARE PROFESSIONAL ON A PHONE CALL REGARDING A PATIENT WHO WAS MONITORED UNDER A CLINICAL RESEARCH STUDY. A SET OF SIMULATED PATIENT DATA (DEMO DATA) HAD BEEN UPLOADED TO ACTUAL PATIENT RECORD DATA INADVERTENTLY AND WAS INTERPRETED AS ACTUAL PATIENT DATA AT THE TIME OF INITIAL DIAGNOSIS. THIS PRODUCT MALFUNCTION CAUSED THE RESEARCH STUDY PATIENT TO BE INCORRECTLY DIAGNOSED WITH ATRIAL FIBRILLATION WHEN INITIAL DIAGNOSIS WAS DONE. THE PATIENT AND HIS PHYSICIAN WERE NOTIFIED OF THIS INCORRECT DIAGNOSIS. ONE OF THE MONITORING TECHNICIANS, WHILE FINALIZING THE PATIENT REPORT LATER, NOTICED THE ERROR AND NOTIFIED THE PHYSICIAN ON THE RESEARCH TEAM. THE PHYSICIAN ON THE RESEARCH TEAM NOTIFIED THE PATIENT AND HIS PHYSICIAN OF THE ERROR AND PROVIDED CORRECT DIAGNOSIS. NO THERAPY WAS ADMINISTERED TO THE PATIENT BASED ON THE INITIAL INCORRECT DIAGNOSIS. NO PATIENT INJURY OR HARM WAS RESULTED AS AN OUTCOME OF THE EVENT. THE SIMULATED DATA WAS LATER SUCCESSFULLY REMOVED AND ORIGINAL CORRECT DATA WAS RESTORED INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296106 ↗
• InjuryAug 11, 2020Thermal Decomposition of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated; Thermal Decomposition of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AN ADVERSE EVENT INVOLVING LI-ION BATTERY PACK WHICH IS COMPONENT OF INFOBIONIC MOME KARDIA DEVICE WAS REPORTED BY MEDICAL PRACTICE STAFF. THE EVENT WAS REPORTED TO BE HAPPENED AT THE PRACTICE LOCATION WHILE PATIENT WAS FITTED WITH MOME KARDIA DEVICE FOR AMBULATORY ECG MONITORING AND GOING THROUGH ANOTHER SEPARATE PROCEDURE OF EEG. FOLLOWING WAS EMAILED BY PRACTICE CONTACT PERSON, "THE PATIENT WAS FITTED WITH THE DEVICE ON THE LEFT SIDE OF THE ABDOMEN. AFTER A WHILE SHE WAS PLACE ON LYING FACE UP ON A BED WHERE SHE WAS GOING TO HAVE AN EEG, SUDDENLY THERE WAS SMOKE COMING OUT OF THE PATIENT'S SHIRT AND THE EEG TECH NOTED SPARKS AND PATIENT SCREAM BECAUSE OF THE PAIN UP OFF THE BED AND PULL THE DEVICE OFF. WHEN SHE PULLED HER SHIRT UP SHE HAD AN AREA OF SKIN LOSS SURROUNDED WITH BLACK MARKS. THERE WAS AN INTENSE SMELL IN THE OFFICE OF BURN PLASTIC AND BURNED SKIN. SHE WAS THEN SEEN BY ONE OF OUR DOCTORS." DURING THE INITIAL NOTIFICATION CALL THE PRACTICE CONTACT PERSON STATED THAT ONE OF THE DEVICES EXPLODED ON THE PATIENT WHEN THE DEVICE WAS ON THE PATIENT AND CAUSED SEVERE BURNS TO THE PATIENT. THE BATTERY WAS REPORTED TO BE MELTED AND CAUSED 2ND DEGREE BURNS TO THE PATIENT ON TOR

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10393631 ↗