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

Catalog Number	MU20500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to dräger that a leak of the humidifier occurred and that the operators decided to replace the device.There was no patient data in the user facility report but dräger cannot exclude that the observation was made during use and led to delay in therapy - thus, this report is filed in abundance of caution.
Additional Manufacturer Narrative
The user facility did not involve the local dräger s&s organization in any follow-up measures; a third-party service provider was involved to check the device and repair it.Dräger has contacted the hospital to obtain additional information but it was responded that no further details can be provided.This does not allow a case-specific evaluation; only a general assessement can be made.A leak from the humidifier will be obvious for the user due to the water spill.The device will post an alarm if the set humidity level cannot be maintained for whatever reason.A reliable conclusion in regard to the root cause for the leak cannot be made.However, dräger has received similar events in the past of which the evaluation had revealed that no de-ionized water was used as recommended which has finally led to malfunction of the humidifier.It would be imaginable that the same explanation applies here as well.H3 other text : device was not available.

• Brand Name: INCUBATOR C2000
• Common Device Name: INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer Contact: 6 tech drive; andover, MA ; 2156602400
• MDR Report Key: 18596572
• Report Number: 2510954-2024-00002
• Device Sequence Number: 15459997
• Product Code: FMZ
• UDI-Device Identifier: 04049098000222
• UDI-Public: (01)04049098000222(11)140613(93)MU20500-38
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2024

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: 12/22/2023
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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