MAUDE Adverse Event Report: DRAEGER MEDICAL INFANT CARE, INC. RESUSCITAIRE WITH AUTOBREATH; INFANT RADIANT WARMER

Model Number	MU20512
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
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 controller of the unit had burned during the pre-use warmup.The biomed further clarified that smoke was billowing out of the unit, but no evacuation was required.There was no report of visible flames, but the soot trails indicate a fire.There was no injury reported in association with this event.
Additional Manufacturer Narrative
The controller was requested for investigation and was evaluated by this investigator.The controller s/n: (b)(4) was received covered in soot and dust.The controller was disassembled and the k4 solid state relay on the pcb2 power board was shorted and heat stressed.The pcb2 power board traces were damaged in the location of the k4 solid state relay.Root cause was identified as a shorted k4 solid state relay on the pcb2 power board (8130870-rev.17, sw0706).The pcb2 power board was made in february of 2006.The board was noted as 16 years old.The resuscitaire service test instructions, maintenance interval overview section shows the pcb2 power board requires replacement every 6 years.To repair the device, the controller will need to be replaced.The complainant was provided this information.
Event or Problem Description
It was reported that the controller of the unit had burned during the pre-use warmup.The biomed further clarified that smoke was billowing out of the unit, but no evacuation was required.There was no report of visible flames, but the soot trails indicate a fire.There was no injury reported in association with this event.

• Brand Name: RESUSCITAIRE WITH AUTOBREATH
• Common Device Name: INFANT RADIANT WARMER
• 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: 14501441
• Report Number: 2510954-2022-00003
• Device Sequence Number: 14621900
• Product Code: FMT
• UDI-Device Identifier: 04049098000185
• UDI-Public: 04049098000185
• Combination Product (Y/N): N
• PMA/510(K) Number: K120642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: MU20512
• Device Catalogue Number: MU20512
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2006
• 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