MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC ISOLETTE 8000 PLUS; CONVENTIONAL INFANT INCUBATOR

Catalog Number	MU20602
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
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.
Additional Manufacturer Narrative
It was reported to draeger that the i8000 plus incubator continued to heat at maximum power in skin mode even though the skin temperature was good.Additional information was requested, and the customer appears to be using the device correctly, using draeger skin probes, proper skin probe placement and monitoring the patient temperature.A dreager technician went onsite and evaluated the device.The draeger technician found no problems with device.However, he did mention that a grommet was missing on the left side of the hood.A missing grommet on the hood would cause an air leak and the heater too run at maximum power to maintain the incubator temperature.Root cause has been identified as an air leak due to a missing grommet.The device was tested and returned to use.No further issues have been reported.
Event or Problem Description
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.

• Brand Name: ISOLETTE 8000 PLUS
• Common Device Name: CONVENTIONAL INFANT INCUBATOR
• 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: 18621689
• Report Number: 2510954-2024-00003
• Device Sequence Number: 2368631
• Product Code: FMZ
• UDI-Device Identifier: 04049098090612
• UDI-Public: (01)04049098090612(11)200306(17)220305(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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2020
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown