IH-Incubator L 009303Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969226344), received between Jul 26, 2019 and May 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMay 17, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THE IH-INCUBATOR L (FIRST INSTALLED 2019) WAS OVERHEATING AND STARTED GIVING OFF A BURNING SMELL. AFTERWARDS, THE ICONS ON THE TOUCH SCREEN WERE NO LONGER RESPONSIVE. NOBODY WAS HARMED BY THIS INCIDENT. A TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE CUSTOMER NOT TO USE THE INSTRUMENT. THEY WERE USING AN ORTHO INCUBATOR UNTIL A REPLACEMENT UNIT ARRIVED.. THE AFFECTED INSTRUMENT WAS SENT TO THE PRODUCT SUPPORT LAB IN PARSIPPANY NJ FOR TROUBLESHOOTING. THERE, THE INSTRUMENT WAS INSPECTED AND TESTED TO SEE IF THE PROBLEM WAS REPLICABLE AND TO FIND THE SOURCE OF THE PROBLEM. THE POWER SUPPLY AND FUSE HOLDER WAS INSPECTED: NO BURNS OR MANUFACTURING DEFECTS WERE FOUND. THE INCUBATOR POWERED ON WITHOUT ISSUES. THE TOUCH SCREEN IS RESPONSIVE AND FUNCTIONAL. THE INSTRUMENT WAS LEFT ON FOR A FULL WORKING DAY AND NEITHER OVERHEATING NOR A BURNING SMELL COULD BE NOTICED. THE INSTRUMENT WENT INTO STANDBY MODE AS INTENDED AND DID NOT FAIL TO POWER BACK ON AFTER TOUCHING THE SCREEN. OTHER THAN DUST BUILDUP ON THE BLADES AND FILTER OF THE FAN, NO DAMAGE OR DEFECTS HAVE BEEN FOUND FOR THE INSTRUMENT'S INTERNAL COMPONENTS. THE INSTRUMENT HAS BEEN TURNED ON, PUT IN STANDBY, AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946832 ↗
• MalfunctionJul 26, 2019Break; Device Emits Odor; Failure to Power Up; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED THAT THE IH-INCUBATOR WOULD GIVE A BURNING SMELL AND WOULD NOT POWER UP. ONE OF OUR FIELD SERVICE ENGINEERS WAS ON SITE TO CHECK ON THE INSTRUMENT. THE CUSTOMER TOLD HIM THAT THEY HAD POURED SALINE OVER THE DEVICE INTO ANOTHER CONTAINER, MISSED AND DUMPLED AT LEAST A 1/2 GALLON OF SALINE ON TOP OF THE DEVICE. THIS CAUSED A BURNING SMELL AND DAMAGED THE DEVICE. THE CUSTOMER POWERED DOWN THE IH-INCUBATOR RIGHT AFTER THIS OCCURRED AND LET IT SIT. OUR FIELD SERVICE ENGINEER DID NOT SEE ANY PHYSICAL DAMAGE TO THE OUTSIDE OF THE DEVICE. WHEN TRYING TO POWER UP THE DEVICE, IT WOULD NOT POWER UP. THE FIELD SERVICE ENGINEER ASKED THE CUSTOMER IF ANY BODILY HARM OCCURED, BUT THERE WAS NONE. NO ERRONEOUS SAMPLE RESULTS OCCURRED. THE DEVICES WAS NOT BEING USED AT THE TIME THIS INCIDENT OCCURRED. THE MAIN BOARD AND THE POWER SUPPLY WAS CHECKED. THE IH-INCUBATOR WAS DAMAGED BECAUSE OF A HANDLING FAILURE BY THE CUSTOMER. THE USER MANUAL CONTAINS A CLEAR SAFETY NOTE, SAYING: "! DANGER, CONTACT WITH WATER: THE IH-INCUBATOR L IS NOT PROTECTED AGAINST WATER PENETRATION. WATER PENETRATING THE INSTRUMENT MAY CAUSE AN ELECTRICAL DISCHARGE. DO NOT INSTALL THE IH-INCUBATOR L NEAR WAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8829953 ↗