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

Model Number	N/A
Medical Device Problem Codes	Computer Software Problem (1112); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported that the infinity central station (ics) unexpectedly restarted during the export of logfiles using the universal serial bus (usb) port on the front of the housing.Patient monitoring was interrupted at the ics during the restart, but monitoring continued at all local monitoring devices that were connected to the ics at the time of this event.The usb port in the rear of the housing was then used to export the logfiles and the device behaved as expected.There was no report of adverse patient impact.
Event or Problem Description
It was reported that the infinity central station (ics) unexpectantly restarted during the export of logfiles using the universal serial bus (usb) port on the front of the housing.Patient monitoring was interrupted at the ics during the restart, but monitoring continued at all local monitoring devices that were connected to the ics at the time of this event.The usb port in the rear of the housing was then used to export the logfiles and the device behaved as expected.Additionally, this resulted in a corrupt log file that could not be opened.There was no report of adverse patient impact.
Additional Manufacturer Narrative
Video of the shutdown as well as a review of the ics logs confirmed the unexpected shutdown.The ics logs also confirmed that the system restarted 5 seconds later with monitoring of the telemetry devices continuing 17 seconds after that.The instructions for use (ifu) states that once the ics is back online it automatically resumes patient monitoring and backfills trends saved in the local database of all monitoring devices.The investigation revealed that when log files are too large and a download is attempted using "copy logs" in the front usb port, the download can exceed the time set in the software, resulting in a corrupted log file and a logarchiver reboot of the system.The draeger technician confirmed that the log download was successful when using the rear usb ports.The customer biomed can also successfully download logs using "filecollect" in the system console with a usb3 for a faster export.

• 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: 22796512
• Report Number: 1220063-2025-00046
• Device Sequence Number: 15614097
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)171027(93)MS26800-30
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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 Model Number: N/A
• Device Catalogue Number: MS26800
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2017
• 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
• Patient Sex: Unknown