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

Model Number	MU20500
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that the nurse set the temperature of the incubator to 32.5 ° c, ready to receive new patients.Half an hour after the patient was put in, the nurse found that the setting temperature of the warm box was 35.0 during the inspection, but the machine did not give an alarm at that time.The temperature of the patient was detected as 37.3 (skin).The warm box was immediately replaced and sent to the equipment department for maintenance.Follow-up monitoring of the patient's body temperature was normal.No adverse patient impact was reported.
Additional Manufacturer Narrative
Based on the reported issue, where the nurse set the temperature of the incubator to 32.5 ° c and half an hour after placing the baby in the incubator she noticed the set temp had changed to 35.0.The nurse used an external skin thermometer to determine the babies temperature at the time as 37.3.No adverse patient impact was reported.The babies temperature prior to being placed in the incubator was not provided.As the set temp was set for 35.0 when the baby¿s temp was 37.3.There is no indication the incubator impacted the baby¿s temperature.The set temp changing from what was selected can occur if the factory default setting are restored.This can occur if the power is lost for more than 10 minutes or the power is lost for less than 10 minutes and the controller memory fails.For either of these conditions, an alarm is provided.The fse recommended replacement of the controller cpu board which contains the memory backup circuit.Therefore, root cause is consistent with a failure of the controller cpu board memory backup circuit.The customer chose not to have draeger repair the device.
Event or Problem Description
It was reported that the nurse set the temperature of the incubator to 32.5 ° c, ready to receive new patients.Half an hour after the patient was put in, the nurse found that the setting temperature of the warm box was 35.0 during the inspection, but the machine did not give an alarm at that time.The temperature of the patient was detected as 37.3 (skin).The warm box was immediately replaced and sent to the equipment department for maintenance.Follow-up monitoring of the patient's body temperature was normal.No adverse patient impact was reported.

• Brand Name: INCUBATOR C2000
• Common Device Name: INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY
• Manufacturer (Section D): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA
• MDR Report Key: 15193614
• Report Number: 2510954-2022-00007
• Device Sequence Number: 20219277
• 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): 09/22/2022

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
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2012
• 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: 1 DA
• Patient Sex: Male