Isolette Infant Incubator, Models C2000 and C2000e MU20500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04049098000222), received between Apr 25, 2022 and Jan 29, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO DRÄGER THAT A LEAK OF THE HUMIDIFIER OCCURRED AND THAT THE OPERATORS DECIDED TO REPLACE THE DEVICE. THERE WAS NO PATIENT DATA IN THE USER FACILITY REPORT BUT DRÄGER CANNOT EXCLUDE THAT THE OBSERVATION WAS MADE DURING USE AND LED TO DELAY IN THERAPY - THUS, THIS REPORT IS FILED IN ABUNDANCE OF CAUTION.

  Patient problems: Insufficient Information

  MAUDE report 18596572 ↗
• MalfunctionJan 22, 2024Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT DURING THE TREATMENT OF PREMATURE INFANT PATIENT IN THE INCUBATOR, THE NURSE SUDDENLY SMELLED THE BURNING ODOR DURING THE TREATMENT. THE INFANT WAS CHECKED TO VERIFY THAT THERE WERE NO TRACES OF BURNS ON THE BABY'S BODY, OR ANY ADVERSE EVENT OR INJURY REPORTED. THE NURSE REPLACED THE INCUBATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552874 ↗
• InjuryJul 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORT THAT "DUE TO PREMATURE BIRTH, THE BODY TEMPERATURE IS NOT CONSTANT, SO THE INCUBATOR IS USED TO ENSURE THE TEMPERATURE OF THE CHILD. CONSTANT, WHEN THE INCUBATOR IS USED, THE WATER TANK LEAKS, WHICH CANNOT PROVIDE A CONSTANT TEMPERATURE AND HUMIDITY ENVIRONMENT FOR THE CHILD, RESULTING IN HYPOTHERMIA FOR THE CHILD, SO IMMEDIATELY REPLACE IT WITH ANOTHER INCUBATOR TO KEEP WARM."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17332755 ↗
• MalfunctionJun 19, 2023Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT DURING USE THE DRAEGER INCUBATOR C2000 POSTED AN ALARM AND THE TEMP AND HUMIDITY DECREASED. THE CHILD WAS ADMITTED TO THE NEONATAL WARD (NICU) AT 00:35 ON (B)(6) 2023 AS PREMATURE AND LOW BIRTH WEIGHT. THE BABY WAS IMMEDIATELY PLACED IN THE INCUBATOR TO KEEP WARM, VENTILATED TO ASSIST BREATHING, PROVIDED INTRAVENOUS NUTRIENT SOLUTION AND OTHER DRUG TREATMENTS. AT 10:00 ON (B)(6), THE INCUBATOR EXPERIENCED A DROP IN TEMPERATURE AND HUMIDITY. IMMEDIATELY REPLACED THE INCUBATOR WITH A NEW ONE TO CONTINUE TREATMENT, AND CONTACTED THE MEDICAL EQUIPMENT DEPARTMENT FOR MAINTENANCE. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17153872 ↗
• MalfunctionAug 9, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE NURSE SET THE TEMPERATURE OF THE INCUBATOR TO 32.5 ° C, READY TO RECEIVE NEW PATIENTS. HALF AN HOUR AFTER THE PATIENT WAS PUT IN, THE NURSE FOUND THAT THE SETTING TEMPERATURE OF THE WARM BOX WAS 35.0 DURING THE INSPECTION, BUT THE MACHINE DID NOT GIVE AN ALARM AT THAT TIME. THE TEMPERATURE OF THE PATIENT WAS DETECTED AS 37.3 (SKIN). THE WARM BOX WAS IMMEDIATELY REPLACED AND SENT TO THE EQUIPMENT DEPARTMENT FOR MAINTENANCE. FOLLOW-UP MONITORING OF THE PATIENT'S BODY TEMPERATURE WAS NORMAL. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15193614 ↗
• MalfunctionJun 29, 2022Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT: AFTER THE NEWBORN WAS OBSERVED AND TREATED IN THE INCUBATOR FOR ABOUT 1 HOUR, THE NURSE ON DUTY FOUND THAT THE INFANT INCUBATOR WAS DOWN. THE BABY WAS MOVED TO A SPARE DEVICE. THE MAINTENANCE PERSONNEL NOTED THAT THE FAN WAS DAMAGED, THE FAN WAS REPLACED TO RESOLVE THE ISSUE. MOVING THE BABY TO ANOTHER DEVICE MAY HAVE RESULTED IN AN INTERRUPTION/DELAY IN THERMOREGULATION TREATMENT.

  Patient problems: Insufficient Information

  MAUDE report 14861932 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REGISTERED NURSE (RN) AT THE CUSTOMER SITE WAS PROMPTED TO THE PATIENT'S ROOM AFTER HEARING THE PATENT'S MOTHER IN DISTRESS. UPON ENTERING THE ROOM, THE RN FOUND THE PATIENT'S MOTHER PICKING UP THE PATIENT FROM THE FLOOR DIRECTLY IN FRONT OF THE INCUBATOR. THE PATIENT'S MOTHER ALLEGED THAT THE INCUBATOR BACK DOOR WAS NOT LOCKED AND THAT THE INCUBATOR DOOR FELL OPEN AND THE PATIENT FELL FROM THE INCUBATOR ONTO THE FLOOR. THERE WERE NO WITNESSES IN THE ROOM WITH THE MOTHER WHEN THE INCIDENT OCCURRED. THE PATIENT WAS DIAGNOSED WITH A HEMATOMA TO THE TOP RIGHT BACK OF THE HEAD. TREATMENT FROM THE EMERGENCY ROOM PHYSICIAN AND RN WAS ADMINISTERED, AND IT WAS DECIDED TO MEDEVAC THE PATIENT TO A HIGHER LEVEL OF CARE FOR FURTHER ASSESSMENT. THE DEVICE WAS CONFIRMED TO BE IN WORKING ORDER AS DESIGNED AT THE TIME OF THE EVENT.

  Patient problems: Fall; Hematoma

  MAUDE report 14196884 ↗