IntelliCart™ 00-5140-102-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00889024466005), received between Jul 3, 2019 and May 30, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY THE POWER INLET MODULE FAILED AND THERE WAS A BURNT SMELL/ODOR. ANOTHER CART WAS BROUGHT IN TO COMPLETE THE SURGERY WITH NO DELAY IN PROCEDURE. THE SURGERY WAS COMPLETED THEN THE FIRE DEPARTMENT CAME IN. THE PATIENT WAS NOT IN THE OPERATING ROOM WHEN THE FIRE DEPARTMENT ENTERED. NO PATIENT INVOLVEMENT. NO HARM REPORTED. DILIGENCE IS COMPLETE. UPON DEVICE EVALUATION IT WAS STATED THAT - THE FAILURE WAS SO CATASTROPHIC THE OR WAS FILLED WITH SMOKE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115017 ↗
• MalfunctionAug 23, 2024Display or Visual Feedback Problem; Failure to Power Up; Communication or Transmission Problem; Display or Visual Feedback Problem; Failure to Power Up; Communication or Transmission Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE WAS POPULATING A COMMUNICATION ERROR AND THE SCREEN WENT BLACK. THEN THE DEVICE WOULD NOT TURN ON. DURING EVALUATION IT WAS FOUND THAT THE DEVICE WAS LEAKING, AND IT WAS DRIPPING ON THE POWER SUPPLY, CAUSING SMOKE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049074 ↗
• MalfunctionApr 19, 2024Sparking; Sparking

  IT WAS REPORTED THAT THE UNIT'S CORD SPARKED AND TRIED TO CATCH ON FIRE WHILE POWERED ON. THE EVENT OCCURRED OUTSIDE OF SURGERY. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143322 ↗
• MalfunctionApr 18, 2024Device Alarm System; Smoking; Unexpected Shutdown; Device Alarm System; Smoking; Unexpected Shutdown

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE IS SMOKING AS IT WAS BEING USED TO SUCTION DURING THE CASE. AFTER IT STARTED TO SMOKE, THE UNIT SHUT DOWN. IT WAS TURNED BACK ON AND AN ALARM STARTED GOING OFF WHILE MORE SMOKE CAME OUT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19138271 ↗
• MalfunctionAug 21, 2023Failure to Power Up; Power Problem; Failure to Power Up; Power Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE CART WOULD NOT POWER UP, WHEN PLUGGED INTO WALL OUTLET. FOUND THE POWER INLET MODULE HAD FAILED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION SOME SLIGHT CHARRING WAS FOUND ON THE FUSE COMPARTMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591807 ↗
• MalfunctionAug 15, 2023Incorrect Measurement; Incorrect Measurement

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548361 ↗
• MalfunctionAug 7, 2023Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up

  NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469852 ↗
• MalfunctionAug 7, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT WAS NOT READING FLUID LEVELS CORRECTLY ON BOTH THE CYLINDERS. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469446 ↗
• MalfunctionJun 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE IV POLE IS MISSING FROM THE UNIT. THE EVENT TIMING IS OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. THE INVESTIGATION FOUND EVIDENCE THAT THE RIBBON CABLE HAD BURN MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083016 ↗
• MalfunctionMay 17, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THERE WAS A FAULTY DISPLAY. THE SCREEN WAS FROZEN. THE EVENT TIMING WAS OUTSIDE SURGERY. THERE WAS NO HARM OR DELAY REPORTED. UPON INVESTIGATION, FUSE HOLDER ON THE POWER INLET MODULE BEING BURNED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945776 ↗
• MalfunctionMay 9, 2023Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895680 ↗
• MalfunctionMay 2, 2023Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up

  IT WAS REPORTED THAT THE UNIT WAS BURNT OUT. THE UNIT HAD NO POWER WHEN PLUGGED INTO THE WALL DUE TO A BURNT POWER INLET MODULE. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856200 ↗
• MalfunctionFeb 21, 2023Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16407533 ↗
• MalfunctionJan 30, 2023Thermal Decomposition of Device; Circuit Failure; Thermal Decomposition of Device; Circuit Failure

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, WHEN THE MACHINE WAS PLUGGED IN IT BURNED THE FUSES AND THE POWER CORD FROM CONNECTION TO MACHINE. NO ADVERSE EVENTS WERE ASSOCIATED WITH THIS MALFUNCTION AS NO PATIENT INVOLVEMENT WAS NOTED. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263933 ↗
• MalfunctionDec 19, 2022Device Emits Odor; Smoking; Device Emits Odor; Smoking

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008586 ↗
• MalfunctionNov 9, 2022Melted; Arcing; Melted; Arcing

  IT WAS REPORTED THAT OUTSIDE OF SURGERY ARCING WAS NOTED ON THE CORD OF THE UNIT. NO PATIENT INVOLVEMENT WAS NOTED AS A RESULT NO DELAY OR HARM EXIST. DILIGENCE IS IN PROCESS; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE EVENT WAS REPORTED AS IT RELATES TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758756 ↗
• MalfunctionOct 13, 2022Thermal Decomposition of Device; Melted; Failure to Power Up; Smoking; Thermal Decomposition of Device; Melted; Failure to Power Up; Smoking

  IT WAS REPORTED THAT THE POWER CORD WAS MELTED, AND THE UNIT NO LONGER POWERS ON. UPON FOLLOW UP IT WAS NOTED THAT THE UNIT DISPLAYED CHARRING AND THERE WAS CORD DAMAGE. NO ADVERSE EVENT WAS REPORTED AS IT RELATES TO THE EVENT. THIS EVENT TOOK PLACE OUTSIDE OF SURGERY AND THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600614 ↗
• MalfunctionSep 1, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT BOTH THE CYLINDERS DOESN'T READ THE FLUID VOLUMES CORRECTLY. THE EVENT TIMING IS OUTSIDE OF SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337507 ↗
• MalfunctionAug 31, 2022Circuit Failure; Failure to Power Up; No Apparent Adverse Event; Circuit Failure; Failure to Power Up; No Apparent Adverse Event

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE POPULATED A DRAIN ERROR AND HAD A BLOWN FUSE ON ITS POWER INLET MODULE. UPON INSPECTION IT WAS NOTED THAT THE POWER INLET MODULE WAS SCORCHED AND BLISTERED. NO ADVERSE EVENTS WERE REPORTED AS IT RELATES TO THIS EVENT AND THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331411 ↗
• MalfunctionAug 24, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT OUTSIDE OF SURGERY IT WAS NOTED THAT THE POWER INLET MODULE'S FUSE BOX WAS BURNT. NO HARM OR DELAY WERE REPORTED AS IT RELATES TO THIS EVENT. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287345 ↗
• MalfunctionAug 23, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THE CART IS GETTING NO POWER. AT PRODUCT EVALUATION INVESTIGATION THE MODULE WAS SHORTED AND BOTH FUSE PORTS WERE BURNED AND BLISTERED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276066 ↗
• MalfunctionAug 15, 2022Fluid/Blood Leak; Sparking; Fluid/Blood Leak; Sparking

  IT WAS REPORTED THE CART ACTED UP DURING A CASE; IT WAS LEAKING WATER, SPARKS FLEW OUT THE BOTTOM, AND IT SHUT OFF THE SOLUTION PANEL IN THE OR. THE EVENT OCCURRED DURING SURGERY, HOWEVER IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224035 ↗
• MalfunctionAug 11, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED UNIT WILL NOT POWER ON WHEN PLUGGED INTO WALL. THE EVENT TIMING WAS NOT DURING SURGERY. NO PATIENT INVOLVEMENT OR HARM. DURING INVESTIGATION, IT WAS FOUND THAT THERE WERE SIGNS OF BURN, FIRE, CHAR. NO HARM NOTED AND NO SMOKE WAS INVOLVED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215043 ↗
• MalfunctionJul 20, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO SURGERY THIS CART WOULD NOT POWER UP. THERE WAS NO PATIENT INVOLVEMENT. AT PRODUCT EVALUATION INVESTIGATION POWER INLET MODULE WAS BURNT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064632 ↗
• MalfunctionJul 19, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CART WOULD NOT CONNECT DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE POWER CORD WAS FRAYED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052215 ↗