MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC ISOLETTE 8000 PLUS; INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY

Model Number	MU20602
Medical Device Problem Codes	Smoking (1585); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
Despite intensive testing, the source of odor could not be clearly identified.It was verified that besides the aspect of odor there are no technical issues with the device.There is no other comparable case known.Since the involved devices have been used for about four years before the smell was noticed it can be excluded that a material and production error is the root cause.Draeger finally concludes that the substance that produced the odor was brought in during use or reprocessing.All concerned plastic parts have been replaced.
Event or Problem Description
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.

• Brand Name: ISOLETTE 8000 PLUS
• 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: 17153857
• Report Number: 2510954-2023-00007
• Device Sequence Number: 11747659
• Product Code: FMZ
• UDI-Device Identifier: 04049098090612
• UDI-Public: (01)04049098090612(11)200612(93)MU20602-11
• Combination Product (Y/N): N
• PMA/510(K) Number: K182977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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 Model Number: MU20602
• Device Catalogue Number: MU20602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• 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 Sex: Unknown