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

Model Number	MU20500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was report that "due to premature birth, the body temperature is not constant, so the incubator is used to ensure the temperature of the child.Constant, when the incubator is used, the water tank leaks, which cannot provide a constant temperature and humidity environment for the child, resulting in hypothermia for the child, so immediately replace it with another incubator to keep warm.".
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
A complaint was received involving a c2000 that leaked water.The user did not perform the operational checkout or prewarm the incubator prior to use.When the temperature did not rise as intended, water leakage was observed.It was verified that the patient did not require any medical intervention as she was placed in a different incubator.The complainant was provided the operation checkout and infant placement instructions from the instructions for use (ifu).It was confirmed that the customer was using sterile water with the device, rather than distilled water as recommended by the ifu.Sterile water contains impurities (minerals, salts, chemicals, etc.) that are known to cause water staining/scaling with use over time, impacting the function of the humidifier module.Therefore, root cause was identified as user error for not following the ifu.Per the ifu, 'caution risk of injury or equipment damage.Use distilled water only (<10 ppm total dissolved solids).Sterile water is not an acceptable substitute for distilled water.' the complainant was provided this information.Based on the delivery date of the device (13may2013), the c2000 was 10 years old at the time of the event (07jun2023).Per the ifu, the expected service life for the c2000 is 7 years.As unclear if hypothermia resulted from the event or if there was a potential delay in treatment.
Event or Problem Description
It was report that "due to premature birth, the body temperature is not constant, so the incubator is used to ensure the temperature of the child.Constant, when the incubator is used, the water tank leaks, which cannot provide a constant temperature and humidity environment for the child, resulting in hypothermia for the child, so immediately replace it with another incubator to keep warm.".

• 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 ; 9784470587
• MDR Report Key: 17332755
• Report Number: 2510954-2023-00010
• Device Sequence Number: 7361352
• Product Code: FMZ
• UDI-Device Identifier: 04049098000222
• UDI-Public: 04049098000222
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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 Model 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: 07/03/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 2 DA
• Patient Sex: Female