Isolette 8000 Infant Incubator MU20600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049098000178), received between Apr 13, 2023 and Jun 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Heating” (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 18, 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.

• InjuryJun 28, 2023Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT DUE TO THE UNSTABLE BODY TEMPERATURE OF THE PREMATURE BABY, THE INCUBATOR WAS USED TO ENSURE THE STABILITY OF THE BABY'S BODY TEMPERATURE. WHEN USING THE INCUBATOR, THE HUMIDIFIER DID NOT HEAT UP, TRIPPED AND CUT OFF THE POWER, WHICH COULD NOT PROVIDE A CONSTANT TEMPERATURE AND HUMIDITY ENVIRONMENT FOR THE BABY, RESULTING IN HYPOTHERMIA AND TUNNELING IMMEDIATELY REPLACE WITH ANOTHER INCUBATOR FOR WARMTH. ADDITIONAL INFORMATION WAS PROVIDED CLARIFYING THAT THE DEVICE FAILED TO TURN ON AS INTENDED WHEN THE BABY WAS LYING IN THE INCUBATOR. THE BABY WAS IMMEDIATELY PUT INTO ANOTHER INCUBATOR. NO OTHER MEDICAL INTERVENTION OR MEASURES WERE TAKEN. IT WAS ALSO STATED THAT THE SITE DOES NOT USUALLY PERFORM THE REQUIRED OPERATIONAL CHECKOUT PROCEDURE PRIOR TO USE. ADDITIONALLY, THE INCUBATOR WAS NOT PREWARMED PRIOR TO PLACING THE BABY IN THE UNIT. THE SITE USES STERILE WATER IN THE DEVICE FOR THE HUMIDITY. AS THE SITE IS USING STERILE WATER INSTEAD OF THE RECOMMENDED DISTILLED WATER FOR THE HUMIDITY, THIS RESULTS IN EARLIER FAILURES OF THE HUMIDITY SYSTEM.

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

  MAUDE report 17221465 ↗
• MalfunctionApr 13, 2023Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THE NURSE NOTICED THAT ONE OF THE SIDE DOORS (HAND PORT) OF THE DRÄGER ISOLETTE 8000 INFANT INCUBATOR WAS OPEN AND PART OF THE NEWBORN'S BODY WAS STICKING OUT THROUGH THE DOOR. ACCORDING TO THEM, THE BABY IS A RATHER HYPERACTIVE CHILD AND IT IS SUSPECTED THAT HE MAY HAVE KICKED THE DOOR OF THE INCUBATOR FROM THE INSIDE AND IT OPENED AS A RESULT. THE INCUBATOR DOOR HAD BEEN OPEN ONCE BEFORE, BUT THE CHILD DID NOT HANG OUT THEN. THE INCIDENT WAS RECORDED AND FORTUNATELY NO ACCIDENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732508 ↗