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

Catalog Number	MS25755
Medical Device Problem Codes	Telemetry Discrepancy (1629); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Draeger has started an investigation, upon completion a follow up report will be submitted.
Event or Problem Description
The customer reported that the m300 monitor is discharged a patient automatically without user initiation.There was no report of adverse patient impact.
Additional Manufacturer Narrative
The m300 log files were reviewed, and it was found that not all the files required to perform a root cause analysis were provided.Additional m300 logs were provided at a later date, which did contain the missing file types, but the date of the event was overwritten so they did not contain information to aid in this investigation.The available m300 log files showed a manual discharge was performed at 11:37.The ics log files provided for this event could not be opened, so this discharge could not be verified at the ics.Instructions for extracting the m300 log files required for investigation were provided and multiple attempts were made to obtain additional log files, however this information was not made available.A root cause could not be determined with the available information.Should the reported behavior recur, the instructions for extracting the m300 log files should be followed, and these files should be provided in combination with the ics log files, along with a network capture from the time of the event and a new investigation could be started.
Event or Problem Description
The customer reported that the m300 monitor is discharged a patient automatically without user initiation.There was no report of adverse patient impact.

• 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: 23465793
• Report Number: 1220063-2025-00055
• Device Sequence Number: 8870179
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)200723(93)MS26800-40
• 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,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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 Catalogue Number: MS25755
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 07/23/2020
• 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
• Patient Sex: Unknown