C6 Sensor 3.0 02-01846Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI B146C6E10), received between Apr 24, 2023 and May 7, 2026 — classified as 1 death, 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026, THE PATIENT EXPERIENCED SKIN IRRITATION RESULTING IN BURN SCARS WHILE WEARING THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNELS. THE PATIENT LATER REPORTED CONCERNS RELATED TO THE MCOT SENSOR 3.0 GOLD PLATES, AS THE PATIENT WAS UNSURE WHETHER THE REACTION WAS CAUSED BY THE SENSOR OR THE PATCH ADHESIVE. THE PATIENT STATED THAT THE BURN WAS NOT RELATED TO SENSOR OVERHEATING OR EXPOSURE TO UNEXPECTED TEMPERATURES. THE PATIENT REPORTED THAT BOTH THE SENSOR AND PATCH WERE EXPOSED TO A 115°F HEATED HOT YOGA ENVIRONMENT. THE PATIENT WAS INFORMED THAT THE SENSOR SHOULD NOT BE WORN IN ENVIRONMENTS WITH EXTREME HEAT, INCLUDING HEATED YOGA ROOMS. HOWEVER, A THE PATIENT REPORTED THAT A HOSPITAL EMPLOYEE ADVISED THAT WEARING THE SENSOR IN THE HEATED YOGA ROOM WAS ACCEPTABLE. THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS AWAITING FOLLOW-UP FROM THEIR PHYSICIAN AT THE TIME OF REPORTING. THE PATIENT SELF-TREATED THE AFFECTED AREA USING NEOSPORIN. IT WAS NOTED THAT THE PATIENT DID NOT PERFORM PROPER SKIN PREPARATION AND USED AN ALCOHOL WIPE PRIOR TO APPLICATION. THE PATIENT REPORTED NO PRIOR HISTORY OF SKIN SENSITIVITY OR ALLERGIES. THE PATIENT WAS EDUCATED ON PROPER DEVIC

  Patient problems: Burn(s); Skin Inflammation/ Irritation

  MAUDE report 25116879 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 PATIENT CALLED REPORTED WHILE SLEEPING HAVING DISCOMFORT FROM WEARING THE DEVICE. PATIENT STATED EXPERIENCING HEADACHES, PRESSURE ON CHEST AND INQUIRED WHAT SHOULD SHE DO. PATIENT SERVICES (PS) RECOMMENDED TO FOLLOW-UP WITH THEIR PHYSICIAN. PATIENT REPORTED THAT THE DEVICE CAUSED DIFFICULTY BREATHING, AND CHEST WAS HURTING. THE PATIENT CONTACTED THEIR DOCTOR AND THEY INSTRUCTED THE PATIENT TO GO TO THE EMERGENCY ROOM (ER). WHILE THE PATIENT WAS IN THE ER, A CT SCAN WAS PERFORMED ON THE PATIENT'S LUNGS. THE PATIENT WAS PLACED ON A NEW HEART MONITOR AND BLOOD WORK WAS RAN. EVERYTHING CAME BACK NORMAL. ADDITIONAL FOLLOW UP INFORMATION FROM PATIENT WAS PROVIDED ON (B)(6) 2025. THE PATIENT REPORTED THE SYMPTOMS IMPROVED AFTER REMOVING THE DEVICE. PATIENT REPORTED THE HEADACHES AND CHEST DISCOMFORT SHE EXPERIENCED 6 MONTHS AGO. PATIENT CONFIRMED THEY WERE ADMITTED TO THE HOSPITAL FROM (B)(6) 2025, AND DID NOT PROVIDE REASON FOR THE ADMISSION. PATIENT STATED THE END RESULTS IS THAT THEY DID NOT FIND ANY ISSUES. PATIENT FOLLOWED UP WITH THE CARDIOLOGIST AND THEY RAN MULTIPLE TEST WITH NO FINDINGS AND IS WAITING FOR A FOLLOW-UP FROM CARDIOLOGIST. HE PATIENT B

  Patient problems: Chest Pain; Dyspnea; Headache

  MAUDE report 24042360 ↗
• InjurySep 30, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT ON (B)(6) 2025, THAT THE MCOT SENSOR - 2.0 - REBUILT SHOCKED THE PATIENT IN THE CHEST. THE PATIENT INDICATED THAT THE SENSOR WAS THE CAUSE AND NOT THE PATCH. THE SHOCK OCCURRED WHEN THE PATIENT WAS AT WORK AND IT FELT LIKE AN ELECTRIC SHOCK. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WASN'T GIVEN ANY MEDICATION; HOWEVER, THE DOCTOR ADVISED THE PATIENT TO SWITCH OVER TO THE LEAD WIRE ADAPTOR (LWA). THE PATIENT DOES NOT HAVE ANY IMPLANTABLE DEVICES AND NO ELECTRONIC WERE AT USE AT THE TIME OF THE SHOCK. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Electric Shock

  MAUDE report 23184385 ↗
• InjuryAug 11, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT ON (B)(6) 2025, THE MCOT SENSOR - 3.0 SHOCKED THE PATIENT AND WAS CAUSING CHEST PAIN, BREAST TENDERNESS AND VISIBLE SORES. THE PATIENT TOOK ASPIRIN TO TREAT THE CHEST PAIN AND LATER SOUGHT MEDICAL ATTENTION. THE PATIENT WAS THEN PRESCRIBED TRIAMCINOLONE CREAM. THE PATIENT REPORTED THAT THE SENSOR WAS OPERATIONAL AFTER THE SHOCK AND THAT THEY HAD NEVER EXPERIENCES THESE SYMPTOMS PRIOR TO THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chest Pain; Tissue Breakdown

  MAUDE report 22771259 ↗
• MalfunctionJul 2, 2025Melted; Overheating of Device; Melted; Overheating of Device

  IT WAS REPORTED ON (B)(6) 2025 THAT THE CHARGING CABLE - SENSOR CHARGE ADAPTER WAS OVERHEATING AND MELTING. THE PATIENT REPORTED THE CHARGER STARTED TO CATCH FIRE AND THERE WAS NO VISIBLE FLAMES. THE PATIENT BELIEVED THAT THE EVENT WAS RELATED TO THE USB PORT OF THE MCOT SENSOR - 3.0. THE PATIENT REPORTED NO INJURIES OCCURRED. NO FURTHER INFORMATION CAN BE PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387693 ↗
• MalfunctionMay 22, 2025Smoking; Smoking

  IT WAS REPORTED ON 23 APRIL 2025, WHEN THE PATIENT WAS ATTEMPTING TO REMOVE THE MCOT SENSOR - 3.0 OUT OF THE BLUE CRADLE IN THE UNIVERSAL PATCH AND THE MCOT SENSOR - 3.0 BEGAN SMOKING. THE PATIENT ADMITTED TO PRYING THE SENSOR OUT. THE PATIENT WAS NOT INJURED. A NEW SENSOR WAS ORDER AND THE PATIENT RETURNED THE SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074630 ↗
• InjuryMar 31, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED ON (B)(6) 2025, PATIENT STATED THEY WERE HAVING A BURNING SENSATION AND SHOCKING WHILE WEARING THE MCOT SENSOR - 3.0. PATIENT REPORTED THE RELATED COMPONENTS THAT WERE INVOLVED WAS THE SENSOR AND THE UNIVERSAL PATCH. PATIENT WAS PERFORMING NORMAL ACTIVITY DURING THE EVENT AND ATTEMPTED PLACING ON A NEW PATCH BUT WITH NO RESOLUTION. PATIENT HAS REMOVED THE DEVICE ON (B)(6) 2025 BUT HAVE BEEN HAVING THE ISSUE OCCUR FOR A WEEK. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025, PATIENT REPORTED THE SYMPTOMS IMPROVED AFTER REMOVING THE DEVICE BUT HAS REMNANTS OF BURN MARKS ON THE SKIN AND THE MUSCLE WAS TENDER. PATIENT HAS NOT EXPERIENCED THE SYMPTOMS PRIOR TO WEARING THE DEVICE. PATIENT REPORTED TAKING A SHOWER ACCORDING TO THE DIRECTIONS AND COVERED THE DEVICE TO PREVENT WATER DAMAGE. PATIENT ALSO STATED THEY WERE NOT SHOWERING AT THE TIME OF THE EVENT BUT NOTICE MOISTURE UNDER THE PATCH WHEN REMOVING THE DEVICE AFTER 5 DAYS AND HAD THE SENSATION ALL WEEK. PATIENT DID NOT REPORT HAVING ANY IMPLANTABLE MEDICAL DEVICES. THERE WAS NO REPORTED ADDITIONAL ELECTRONICS IN USE AT THE TIME OF THE EVENT. PATIENT WAS UNABLE TO PROVIDE THE FREQUENCY OF SHOCK OCCURRENCE WHILE WEARING

  Patient problems: Electric Shock; Superficial (First Degree) Burn

  MAUDE report 21733365 ↗
• InjuryFeb 26, 2025Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ON (B)(6) 2025 THAT THE PATIENT BEGAN SERVICE. ON (B)(6) 2025, THE PATIENT HAD AN EPISODE AT SCHOOL AROUND 10AM WHERE EMERGENCY SERVICES WERE CALLED. UPON FURTHER REVIEW OF FETCHED DATA DETERMINED A SUDDEN ONSET OF SVT ON 21 JANUARY 2025 WHICH WAS SUSTAINED FOR APPROXIMATELY 30 MINUTES. IT WAS NOTED THAT ARTIFACT WAS PRESENT. IT IS UNCLEAR WHY THE SUSTAINED TACHYARRHYTHMIA DID NOT AUTOMATICALLY TRIGGER A SEVERE TACHYCARDIA EVENT. BASED ON THE AVAILABLE INFORMATION, THERE WAS A FAILURE TO AUTO-TRIGGER A SEVERE TACHYCARDIA EVENT.

  Patient problems: Tachycardia

  MAUDE report 21470925 ↗
• InjuryFeb 18, 2025Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED THAT ON (B)(6) 2022 THAT THE PATIENT EXPERIENCED A SYNCOPE EVENT WHILE AT WORK WHILE WEARING THE MCOT SENSOR - 3.0. THE FOLLOWING MORNING THE PATIENT HAD ANOTHER EVENT WHILE STILL WEARING THE DEVICE AND PASSED OUT WHILE DRIVING THEIR CAR. THE PATIENT REPORTED TO THE EMERGENCY DEPARTMENT (ED) AND WHEN THE MCOT SENSOR - 3.0 WAS INTERROGATED IT WAS REPORTED THAT NO EVENTS SHOWED UP ON THE MONITOR. ON AN UNKNOWN DATE AFTER THE PATIENT REPORTED TO THE HOSPITAL AFTER PASSING OUT, HOWEVER THIS TIME THE PATIENT WAS NOT WEARING THE MCOT SENSOR IT WAS DECIDED THE PATIENT WAS TO GO BACK ON 30-DAY MCOT PRESCRIPTION. AFTER ABOUT 3 WEEKS ON SERVICE THE PATIENT HAD ANOTHER SYNCOPE EVENT, AND THE PATIENT WAS CALLED TO REPORT THAT THEY HAD A 17 SECOND PAUSE AND NEEDED TO GO THE ED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER HAD A PACEMAKER IMPLANTED. THE PATIENT BELIEVES THAT THE DUE TO THE FIRST MCOT SENSOR NOT WORKING PROPERLY THEY DID NOT RECEIVE PROPER CARE AND THEREFORE, HAS A DELAY IN TREATMENT.

  Patient problems: Syncope/Fainting

  MAUDE report 21392820 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 16 AUGUST 2024 AFTER RECEIVING THEIR MCOT KIT, IT WAS NOTED THAT IT WAS SOILED AND BECAUSE OF IT BEING SOILED IT GAVE THE PATIENT A SKIN INFECTION. THE PATIENT REPORTED THAT THEY HAVE AN IRRITATION UNDERNEATH THE PATCH. THE PATIENT CONTINUED BY STATING THE PATCHES WEREN'T SOILED, BUT THE SENSOR WAS AND BECAUSE THE SENSOR WAS HANDLED IT NOW CREATED AN INFECTION ON THE SKIN. THE PATIENT SAID THEY HAVE 6 DOTS THAT ARE OOZING WITH BLOOD AND PUS. THE PATIENT SAID THEY USED SOAP AND WATER ONLY TO PREP THE SKIN. THE PATIENT SAID THEY CONTACTED THEIR DOCTOR ABOUT SENDING A SOILED DEVICE AND THE PATIENT CLAIMS THEIR DOCTOR SAID IT WAS URGENT FOR THEM TO GET THEIR HEART MONITORED. THE PATIENT CONTINUED BY STATING THAT NO ONE TOLD THEM TO PUT ON THE SOILED DEVICE ON BUT SINCE THEY HAVE HEART ISSUES, THEY FELT THAT THEY SHOULD WEAR IT ANYWAY. THE PATIENT ATTEMPTED TO CLEAN THEY DEVICE THEMSELVES BY USING ISOPROPYL ALCOHOL AND A TOOTHBRUSH TO CLEAN ALL THE NOOKS AND CRANNIES. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION FOR THE IRRITATION AT THIS TIME AND REPORTED NO HISTORY OF SKIN SENSITIVITIES. THE PATIENT ALSO REPORTED THAT THE IRRITATION OCCURRED 24 HOURS PRIOR AND SIN

  Patient problems: Unspecified Infection

  MAUDE report 20214602 ↗
• DeathJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 THE PATIENT BEGAN MCOT MONITORING. IT WAS REPORTED ON (B)(6) 2024 THAT ON (B)(6) 2024 THE PATIENT PASSED AWAY AND THE SENSOR WAS LOST BY EMS. THE EXACT CAUSE OF DEATH IS UNKNOWN. IT IS KNOWN THAT THE PATIENT'S HUSBAND FOUND HER, AND CPR WAS PERFORMED. EARLIER IN THE WEEK ON AN UNKNOWN DATE THE PATIENT HAD A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE AND SOMETIME POST TAVR PROCEDURE THE PATIENT EXPERIENCED HEARTBLOCK. IT IS UNKNOWN IF THE PATIENT HAD HISTORY OF HEARTBLOCK PRIOR TO THE TAVR PROCEDURE. OUTSIDE OF THE TAVR PROCEDURE THE PATIENT'S MEDICAL HISTORY IS UNKNOWN.

  Patient problems: Atrial Fibrillation; Heart Block

  MAUDE report 19711657 ↗
• InjuryJun 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED ON (B)(6) 2024, A ONE YEAR OLD PATIENT WAS BURNED BY THE MCOT SENSOR - 3.0 AND CAUSED A SKIN IRRITATION. THE PATIENT'S MOTHER TURNE POWERED OFF TEH DEVICE AND REMOVED IT FROM THE PATIENT. A REPLACEMENT KIT WAS ORDERED AND FLEX ADAPTER WITH CLOTH ELECTRODES WERE OFFERED. THE PATIENT WAS TAKING A BREAK IN SERVICE FOR A FEW DAYS TO LET THE SKIN HEAL. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER COULD NOT BE OBTAINED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19530287 ↗
• InjuryApr 2, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED ON 18 MARCH 2024, THAT ON (B)(6) 2024 THE PATIENT WAS PLUGGING THE DUAL USB CHARGING PLUG INTO THE WALL OUTLET TO CHARGE THE MCOT SENSOR AND MCOT MONITOR. THE DUAL USB CHARGING PLUG BROKE AND SOMEONE WAS SHOCKED. THE PATIENT STATED THAT THEY ATTEMPTED TO PULL THE CHARGER OUT OF THE WALL OUTLET AND THE PRONGS REMAINED INSIDE THE WALL OUTLET AND THEIR WIFE EXPERIENCED A SHOCK. NO MEDICAL ATTENTION WAS SOUGHT. A REPLACEMENT DUAL USB CHARGING PLUG WAS ORDERED.

  Patient problems: Electric Shock

  MAUDE report 19020516 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 16 FEBRUARY 2024 AFTER THE SENSOR WAS PLACED THE PATIENT STARTED TO EXPERIENCE THEIR THROAT SWELLING, HEADACHES AND DRY MOUTH. ABOUT 30 MINUTES AFTER TAKING THE SENSOR OFF THEIR THROAT WAS NOT SWELLING ANYMORE ON THE OUTSIDE. THEY WERE STILL EXPERIENCING SWELLIN INSIDE THE TROAT. THE PATIENT WENT TO THE DOCTOR AND HAD TESTS AND SCANS PERFROMED HOWEVER, NOTHING COULD BE FOUND. IT IS UNKNOWN WHAT IS THOUGHT TO HAVE CAUSED THE THROAT SWELLING. THE PATIENT DISCONTINUED SERVICE.

  Patient problems: Dry Mouth; Headache; Swelling/ Edema

  MAUDE report 18857715 ↗
• MalfunctionJan 24, 2024Fire; Overheating of Device; Fire; Overheating of Device

  IT WAS REPORTED THAT THE SENSOR BURNED AND STARTED TO CATCH FIRE WHILE CHARGING IN THE CHARGER. THE CHARGER WAS PLUGGED WITH AN EXTENSION CORD. THE PATIENT SERVICES REP INSTRUCTED THE PATIENT WITH PROPER CHARGING INSTRUCTIONS. A RETURN KIT WAS REQUESTED AND A REPLACEMENT WAS ORDER. THERE WERE NO INJURIES OR PROPERTY DAMAGE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576723 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BEGINNING 15 SEPTEMBER 2023, THE PATIENT CALLED AND EMAILED TO REPORT THAT THEY WILL BE RETURNING THE DEVICE BECAUSE THE SECOND BATCH OF VERMED ELECTRODES CAUSED BLISTERS AND BLEEDING FROM GEL THAT LEAKED OUT OF THE ELECTRODES. THE PATIENT SAW THEIR DOCTOR, WHO PRESCRIBED CLOBETASOL PROPIONATE CREAM USP,0.05%. AFTER APPLYING IT TWICE DAILY FOR 14 DAYS, THE PATIENT'S SKIN HEALED BUT NOW HAS SCARRING. THE PATIENT REPORTED THAT THEY CLEANED AND DRIED THEIR SKIN PROPERLY BEFORE APPLYING THE ELECTRODES AND HAS NO PRIOR SKIN SENSITIVITY/ALLERGY.

  Patient problems: Blister; Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation

  MAUDE report 18384673 ↗
• MalfunctionSep 11, 2023Smoking; Smoking

  PARENT REPORTED THAT THE SENSOR WAS DAMAGED AND BEGAN SMOKING WITH ATTEMPTING TO PRY OFF THE PLASTIC COMPARTMENT. THE PATIENT WAS STRUGGLING TO REMOVE SENSOR FROM PATCH AT THE TIME OF THE EVENT. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED AND A REPLACEMENT DEVICE WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17721814 ↗
• MalfunctionJul 6, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE SENSOR MELTED. THERE IS NO REPORTS THAT THE PATIENT WAS HARMED OR SOUGHT MEDICAL ATTENTION. NO ADDITIONAL INFORMATION IS AVALIABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270110 ↗
• MalfunctionJul 6, 2023Melted; Overheating of Device; Melted; Overheating of Device

  THE PATIENT'S WIFE RETURNED THE SENSOR TO CLINIC AFTER HER HUSBAND WORE IT FOR A DAY. NO INJURIES WERE REPORTED BUT AFTER ASSESSING PICTURE IT NOTED THAT THE SENSOR MELTED/BURNED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269863 ↗
• InjuryJun 12, 2023Patient-Device Incompatibility; Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PATIENT REPORTED THAT WAS SENSOR BATTERY WAS ONLY LASTING 2 DAYS AND WAS NOT GIVEN A REPLACEMENT FROM AGENT. AFTER A FEW MORE DAYS THE SENSOR GOT HOT AND BURNED HER. SHE SAID SHE HAD BLISTERS UNDER THE SENSOR AND ELECTRODES IN THE PATCH. SHE HAD TO TAKE THE DEVICE OFF. THE PATIENT WAS ADVISED TO TAKE THE DEVICE OFF AND A REPLACEMENT DEVICE WAS ORDERED AND PATIENT WILL SWITCH TO LWA (LEAD WIRE ADAPTER). ADDITIONAL INFORMATION WAS OBTAINED ON 31 MAY 2023 FROM PATIENT SERVICES AND THE PATIENT: THE PATIENT REPORTED THAT SHE WAS EXPERIENCING PAIN FROM THE AREA WHERE THE PATCH WAS "BLISTERS UNDER THE PATCH" AND "SENSOR GETTING HOT AFTER CHARGING," THE BLISTERS ARE LIKE CIGARETTE BURNS. THE PATIENT STATED THAT SHE WILL BE SEEING HER FAMILY DOCTOR. THE PATIENT ALSO STATED THAT SHE HAS PRE EXISTING SKIN SENSITIVITIES. THE PATIENT WAS PRESCRIBED BURN OINTMENT AND ANTIBIOTIC STEROIDS CREAM FOR SECOND DEGREE BURNS.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 17105280 ↗
• MalfunctionMay 18, 2023Overheating of Device; Temperature Problem; Excessive Heating; Overheating of Device; Temperature Problem; Excessive Heating

  IT WAS REPORTED THAT SPARKS FROM SENSOR AND A BURNING SMELL OF MELTED PLASTIC WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED WITH 3 GFE ATTEMPTS HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956080 ↗
• MalfunctionMay 15, 2023Overheating of Device; Temperature Problem; Excessive Heating; Overheating of Device; Temperature Problem; Excessive Heating

  PATIENT CLAIMS THE SENSOR BURNED THROUGH HIS SHIRT, NO HARM TO THE PATIENT WAS REPORTED. THE SENSOR GOT HEATED AND BURNED THE PATIENT'S SHIRT. THE PATIENT REMOVED THE SENSOR AND RETURNED THE KIT EARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935666 ↗
• InjuryApr 24, 2023Patient-Device Incompatibility; Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PATIENT REPORTED THAT SHE RECENTLY WAS PRESCRIBED TO WEAR YOUR HEART MONITOR FOR 30 DAYS. PATIENT COULD NO LONGER TOLERATE THE HEART MONITOR ON SKIN. PATIENT STATED SKIN WAS BRIGHT RED, BURNT AND HAD WIRE MARKINGS. ADDITIONAL INFORMATION RECEIVED 28 MARCH 2023 FROM PATIENT SERVICES FROM THE PATIENT: THE PATIENT FOLLOWED UP WITH THEIR DOCTOR AND WAS INSTRUCTED TO TAKE THE FOLLOWING MEDICATION WHICH THE PATIENT ALREADY HAD FROM A PREVIOUS CONDITION: (TRIAMCINOLONE 2X DAY UP TO 14 DAYS 15GS ALLERERGY MD OTC CORTIZONE).

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 16795443 ↗