MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC ISOLETTE C2000; INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY

Catalog Number	MU20500
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.H3 other text : device was not available.
Event or Problem Description
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.
Additional Manufacturer Narrative
The device was evaluated by draeger, and the odor was being caused by a foreign material (most likely mineral deposits) getting inside the evaporator.We do not know how the foreign material got into the evaporator.However, it was confirmed the user was not using distilled water as instructed in the instructions for use manual and the odor was eliminated by cleaning the evaporator of this foreign material.
Event or Problem Description
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.

• Brand Name: ISOLETTE C2000
• Common Device Name: INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 18552874
• Report Number: 2510954-2024-00001
• Device Sequence Number: 12727394
• Product Code: FMZ
• UDI-Device Identifier: 04049098000222
• UDI-Public: (01)04049098000222(11)190910(93)MU20500-49
• Combination Product (Y/N): N
• PMA/510(K) Number: K001242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MU20500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Race: Asian