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

Model Number	MU20500
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use the draeger incubator c2000 posted an alarm and the temp and humidity decreased.The child was admitted to the neonatal ward (nicu) at 00:35 on (b)(6) 2023 as premature and low birth weight.The baby was immediately placed in the incubator to keep warm, ventilated to assist breathing, provided intravenous nutrient solution and other drug treatments.At 10:00 on (b)(6), the incubator experienced a drop in temperature and humidity.Immediately replaced the incubator with a new one to continue treatment, and contacted the medical equipment department for maintenance.No adverse patient impact was reported.
Additional Manufacturer Narrative
It was confirmed that the site performs the device maintenance but will call draeger for service if a malfunction occurs.Additional information was requested including what type of water is used in the incubator and if the operational checkout was performed.However, this information was not made available.The device was evaluated by a draeger technician on (b)(6) 2023.The sensor module was replaced to resolve the issue.No further issues have been reported.H3 other text : see h10.

• Brand Name: INCUBATOR 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
• MDR Report Key: 17153872
• Report Number: 2510954-2023-00006
• Device Sequence Number: 3929174
• Product Code: FMZ
• UDI-Device Identifier: 04049098000222
• UDI-Public: (01)04049098000222(11)160104(93)MU20500-43
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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: MU20500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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: Required Intervention
• Patient Age: 5 DA
• Patient Sex: Male