Isolette® 8000 plus MU20602Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049098090612), received between Jun 19, 2023 and Jul 3, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE RESULT OF THEIR MEASUREMENTS WAS SIGNIFICANTLY GREATER X-RAY ATTENUATION IN THE BASE OF THE DRAEGER ISOLETTE WHEN COMPARED TO THE CUSTOMER OTHER NON-DRAEGER INCUBATORS. THE CUSTOMER STATED THAT, WHEN USING THE SAME EXPOSURE PARAMETERS(70KV &0.5MAS), THE MEASURED EXPOSURE TO THE IMAGE RECEPTOR IN THE NEW INCUBATOR WAS 45-48% LESS THAN COMPARED TO THEIR OTHER INCUBATOR. IN ORDER FOR THE USERS TO ACHIEVE A BETTER EXPOSURE, THEY INCREASED THE PARAMETERS FROM .05MHS TO .08MHS, AND STATED THAT THIS WOULD INCREASE THE PATIENT DOSE BY ABOUT 60%. THERE WAS NO PATIENT INJURY OR ADVERSE PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19666846 ↗
• InjuryFeb 1, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE CONTINUED TO HEAT AT MAXIMUM POWER IN SKIN MODE EVEN THOUGH THE SKIN TEMPERATURE WAS GOOD. WHICH LED TO A BABY HYPERVENTILATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621689 ↗
• MalfunctionJun 19, 2023Smoking; Device Contamination with Chemical or Other Material; Smoking; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED A CONTINUOUS BURNING RUBBER SMELL IN THE INCUBATOR WHEN IN USE. THE INCUBATOR IS IN THE BIOMEDICAL DEPARTMENT BECAUSE THE STAFF IS CONCERNED ABOUT THE SMELL BEING TOXIC FOR THE BABY INSIDE THE INCUBATOR. NO ADVERSE PATIENT IMPACT WAS REPORTED. AS THE CAUSE OF THE SMELL HAS NOT BEEN DETERMINED, WE CANNOT EXCLUDE THE ODOR POTENTIALLY PERMEATING INTO THE PATIENT COMPARTMENT OR DETERMINE IF THE SOURCE IS TOXIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153857 ↗