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

Catalog Number	MU20503
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025 the positive end-expiratory pressure (peep) was too low when the mask was first placed on the patient's nose and mouth.It was noted that when the tube was plugged in and ventilation was turned on, the peep values would fluctuate depending on if the tube was attached or detached, especially when the hole from above was closed.The base rate of the flow would change.The patient was a premature baby with pneumothorax and a chest tube was inserted as a measure.The device was tested on (b)(6) 2025 and was found to operate according to manufacturer's specification.
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted following the completion of the manufacturer's investigation.
Additional Manufacturer Narrative
A draeger service engineer has evaluated device and accessories on-site whereby no deviations from specification could be found.The most likely root cause for the fluctuating peep could be identified in the settings: the device has two gas outlets at its resuscitation module for the purpose to supply the mother or a twin baby in parallel if necessary.The ifu's (instructions for use) of both device and patient circuit emphasize that all ventilation parameters have been set using a test lung before start of patient treatment and warns that otherwise the patient may be put at risk.When performing this pre-use check with a patient circuit connected to the one gas outlet, the flow control valve of the other gas outlet has to be closed, otherwise no stable values for peep and pip can be adjusted.The service engineer could determine that the second flow control valve was also opened when he checked the device.It is seen likely that this was the case during pre-use check and course of event, too.The ifu of the breathing circuit further explains that the peep depends on the flow and thus changes on flow adjustments, and the document describes in the following that the airway pressure during resuscitation has to be monitored continuously and readjusted if necessary.A flow increase initiated at a time a leak is present at the face mask may result in unexpected high pip when the leak is reduced by e.G.Firmly pressing the mask to the patient¿s face.Draeger finally concludes that the event must be attributed to use error ¿ the device was used on a patient without being able to adjust stable settings before, and it cannot be excluded that the countermeasures initiated during use have contributed to the patient outcome as well.Results of dräger¿s evaluation have been discussed with the customer.
Event or Problem Description
A complaint was received regarding the resuscitaire having the peep (positive end-expiratory pressure) too low and fluctuating when the mask is first placed on the patient's nose and mouth.The customer increased the flow which increased pip (peak inspiratory pressure) and subsequently peep, and when they adjusted the mask to reduce the leak it caused a pneumothorax.

• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784097390
• MDR Report Key: 22386938
• Report Number: 2510954-2025-00002
• Device Sequence Number: 20608058
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)180815(17)200808(93)MU20503-51
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: MU20503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2018
• 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: Required Intervention
• Patient Sex: Unknown