MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS26800
Medical Device Problem Codes	Communication or Transmission Problem (2896); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted following the completion of the manufacturer's investigation.
Event or Problem Description
The infinity m300 patient monitors were reported to have discharged from the infinity central station (ics) without any user interaction.According to the customer, the ics displayed a ¿discharge¿ message at the time of the event, while all patient data remained accessible in the trend tab.The m300 monitors were successfully readmitted, allowing patient monitoring to continue without interruption.No adverse patient impact was reported.
Additional Manufacturer Narrative
Investigation into the reported event revealed that although the ics displayed "discharged" in the viewport of the m300, the m300 believed it was still connected to the ics and continued monitoring locally, resulting in a mismatched state between the two devices.All historic patient data did remain accessible for the affected m300 under the trend/data tab at the ics.A review of the ics log files showed the user frequently changed viewports of admitted m300 patients.This move operation allows users to configure the location of where an m300 is displayed at the ics by assigning them to new a viewport.The ics log files also revealed that following the use of the move operation at this hospital, in many of the cases, the m300 would go offline; after which, the m300 would show as discharged in both its previous viewport and newly assigned viewport on the ics.Draeger was able to reproduce this behavior in a lab by interrupting the network connection while changing the viewport of an m300.It was confirmed the ics would think the m300 was discharged due to this minor network impairment occurring at the same time as the move operation, despite the m300 still being in use.Of note this hospital's workflow is unique in that they are using the move operation very frequently; therefore, the likelihood of occurrence is increased.Minor network impairments are expected to occur and are not considered to be a fault of the network.As the issue can only occur during user interaction when attempting to move an m300 from one viewport to another, this would be obvious to the user.In conclusion an issue within the ics software's network communication which handles the reacquisition of an m300 that goes offline was identified.An update to the ics software to address how the ics reacquires m300s when network impairments occur will be made in a future software release.
Event or Problem Description
The infinity m300 patient monitors were reported to have discharged from the infinity central station (ics) without any user interaction.According to the customer, the ics displayed a ¿discharge¿ message at the time of the event, while all patient data remained accessible in the trend tab.The m300 monitors were successfully readmitted, allowing patient monitoring to continue without interruption.No adverse patient impact was reported.

• Brand Name: INFINITY CENTRAL STATION
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• 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: 22475438
• Report Number: 1220063-2025-00040
• Device Sequence Number: 15439629
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)190705(93)MS26800-36
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: MS26800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown