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

Model Number	MU20503
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that an event occurred where the involved patient died.The users noted the warmer [resuscitaire] was malfunctioning and had provided a check temp alarm.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
Additional information was requested including clarification of the alarm provided (there is no "check temp" alarm), what mode the device was in and patient information however, no further information was provided.A draeger technician evaluated the device and found no issues with the performance of the device.Therefore, root cause could not be determined.
Event or Problem Description
It was reported that an event occurred where the involved patient died.The users noted the warmer [resuscitaire] was malfunctioning and had provided a check temp alarm.

• Brand Name: RESUSCITAIRE RADIANT WARMER
• 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: 15374678
• Report Number: 2510954-2022-00009
• Device Sequence Number: 5613569
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: 04049098000215
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: MU20503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown