MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC BABYROO TN300; INFANT RADIANT WARMER

Catalog Number	MU20300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The customer reported that the babyroo was set to 36.9 celsius with no humidifier, to warm the baby that had a skin temperature of 36.2°c.The customer reported that baby's skin on the rear of the the thigh was burnt (red skin), and that the device did not trigger any alarm, and that the radian was warm.Additional information from the customer stated that the degree was first degree, and that there was a slight redness present on the calf that went away within 30 minutes of a cold compress.There was no other follow up and no blistering.The additional information provided stated that the baby was within hours of being born, and weighed 2.340 kg.The baby was moved away from the radian in a location that kept the baby warm but not directly heated, and a pediatrician was called in.The patient was confirmed to be in good condition with no remaining consequences.The customer confirmed that the pre-use checkout was performed, and that they did not use a heated warmer.A central skin temperature probe was positioned on the abdomen and secured with a suitable device.The baby had no clothing, just a nappy with a cap over his head.
Event or Problem Description
The customer reported that the babyroo was set to 36.9 celsius with no humidifier, to warm the baby that had a skin temperature of 36.2°c.The customer reported that baby's skin on the rear of the thigh was burnt (red skin), and that the device did not trigger any alarm, and that the radian was warm.Additional information from the customer stated that the degree was first degree, and that there was a slight redness present on the calf that went away within 30 minutes of a cold compress.There was no other follow up and no blistering.The additional information provided stated that the baby was within hours of being born and weighed 2.340 kg.The baby was moved away from the radian in a location that kept the baby warm but not directly heated, and a pediatrician was called in.The patient was confirmed to be in good condition with no remaining consequences.The customer confirmed that the pre-use checkout was performed, and that they did not use a heated warmer.A central skin temperature probe was positioned on the abdomen and secured with a suitable device.The baby had no clothing, just a nappy with a cap over his head.
Additional Manufacturer Narrative
It was reported to draeger that a babyroo (without the heated mattress), did not provide audible alarms for high temperature or radiant overheating which resulted in an injury.A clinician that monitored the patient after a 10-minute interval noticed a red mark on the patient's thigh.The hospital clinician stated it to be slight redness on the calf, which was resolved with a cold compress for 30 minutes.Additional information stated this was a first-degree burn on the patient's thigh which completely resolved within 12 hours with cold-water compresses.Further clarification was received that the patient had no clinical signs of overheating, and the baby was calm and asleep.The device was evaluated by a drager technician who conducted a functional test on the device.Service report and the associated checklist indicate that the function test with the skin temperature probe verified the device was working according to specifications.And a log recovery was made.The device logs were evaluated by a draeger software engineer.Considering the device tested according to specifications by the drager technician, the reviewed logs indicate low skin temperature alarms and user interaction, the skin temperature never exceeding 37.3c or reaching a temperature that would generate a high temperature alarm and the statement that there were no clinical signs of patient overheating, the exact root cause of the reported superficial skin redness is unknown at this time.The device remains in use at the customer site.The instructions for use (ifu) indicate that the alarm volume range for the babyroo is 50 to 65 db(a) and warns that if the alarm volume is too low, or if the user is too far away from the device, alarm signals may not be heard.It further cautions that patient core temperature and skin probe position should be routinely monitored, alarm limits that can be set by the user should be verified for new patients, and acoustic alarms are generated through a reserve speaker if the event of main loudspeaker failure.The complainant has been provided this information for the customer.

• Brand Name: BABYROO TN300
• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 2156602400
• MDR Report Key: 19430376
• Report Number: 2510954-2024-00027
• Device Sequence Number: 8010523
• Product Code: FMT
• UDI-Device Identifier: 04049098099042
• UDI-Public: (01)04049098099042(11)230627(93)MU20300-12
• Combination Product (Y/N): N
• PMA/510(K) Number: K230278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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?: No
• Device Catalogue Number: MU20300
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 DA
• Patient Sex: Unknown
• Patient Weight: 2 KG