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

Catalog Number	MU20503
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that a draeger resuscitaire had an error 5.There were photographs provided showing that the warmer hood of the device was melted.It was noted that there was a patient involved, however; the customer stated that there was no adverse event or injury reported.
Additional Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.
Event or Problem Description
It was reported by the customer that a draeger resuscitaire had an error 5.There were photographs provided showing that the warmer hood of the device was melted.It was noted that there was a patient involved, however; the customer stated that there was no adverse event or injury reported.
Additional Manufacturer Narrative
A compliant was received regarding the draeger resuscitaire warmer head cover melted.It was stated that the device was in use, however; there was no patient injury or further information provided regarding the patient.A picture was provided showing the melted hood and the charring.The customer was asked if there were any objects placed on top of the hood and this information could not be confirmed.The damage in the provided image is consistent with prolonged heat stress due to blocked vents.The customer informed us that there was additional training given to the staff.No further issues have been reported.The resuscitaire instructions for use (ifu) was provided to the customer to assist in continued education for safe practices.The resuscitaire instructions for use (ifu) provides the following: caution - before placing the infant in the warmer, pre-warm the device to the temperature prescribed by the attending physician.Failure to do so could result in patient injury; warning - to avoid risk of fire or overheating the warmer, never block the vents on top of the warmer.Patient injury or equipment damage could occur; warning - to avoid risk of fire or overheating the warmer, never place objects, such as blankets, clothing, diapers, or sterile packs, on top of the warmer.These objects can interfere with the proper cooling of the warmer head and can fall onto the mattress.Patient injury or equipment damage could occur.

• Brand Name: RESUSCITAIRE RADIANT WARMER
• Common Device Name: INFANT RADIANT WARMER
• 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 ; 2156602400
• MDR Report Key: 19249073
• Report Number: 2510954-2024-00026
• Device Sequence Number: 6381070
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)200925(93)MU20503-56
• Combination Product (Y/N): N
• PMA/510(K) Number: K120642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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 Catalogue Number: MU20503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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: Other
• Patient Sex: Unknown