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

Model Number	MU20500
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: after the newborn was observed and treated in the incubator for about 1 hour, the nurse on duty found that the infant incubator was down.The baby was moved to a spare device.The maintenance personnel noted that the fan was damaged, the fan was replaced to resolve the issue.Moving the baby to another device may have resulted in an interruption/delay in thermoregulation treatment.
Additional Manufacturer Narrative
Additional information regarding the patient has been requested.A follow-up report will be submitted upon completion of this investigation.The device was evaluated and repaired by maintenance personnel.
Additional Manufacturer Narrative
Additional information was provided, it was confirmed that there was no adverse patient impact and the incubator had alarmed with a controller failure 4 error message to alert the user of the condition.As previously reported, the controller fan was replaced to resolve the issue.Review of the service history of the device confirmed the controller fan had never been replaced.Based on the serial number, the device was manufactured july of 2012.As indicated in the instructions for use (ifu), as part of the recommended preventive maintenance interval, the controller fan is to be replaced every three years.Therefore, root cause was identified as a lack of maintenance.The complainant was provided this information.No further issues have been reported.H3 other text : the device was evaluated and repaired by maintenance personnel.
Event or Problem Description
It was reported that: after the newborn was observed and treated in the incubator for about 1 hour, the nurse on duty found that the infant incubator was down.The baby was moved to a spare device.The maintenance personnel noted that the fan was damaged, the fan was replaced to resolve the issue.Though no adverse patient impact was reported, moving a baby to another device could result in an interruption/delay in thermoregulation treatment.

• Brand Name: ISOLETTE 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: 14861932
• Report Number: 2510954-2022-00005
• Device Sequence Number: 14650828
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2013
• 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