MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY M300; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

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	09/25/2025
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 and ics log files were reviewed, however, it was found that not all the m300 log files required for performing a root cause analysis were provided.Additionally, although the date of event was confirmed to be 25sep2025, the time of the event was unknown.The available m300 log files showed this device performed a manual discharge on 25sep2025 at 10:05 and the ics log files showed an m300 was manually discharged at 10:06.The ip address of the m300 was needed to confirm these messages correlated, but this information was not provided.Instructions for extracting the m300 log files required for investigation were provided and multiple attempts were made to obtain additional information such as the time of the event, the remaining log files, and the ip address of the m300; however no further information was provided.A root cause could not be determined with the available information.Should the reported behavior recur, the instructions for extracting the m300 log files were provided, 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 M300
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• 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: 23359662
• Report Number: 1220063-2025-00053
• Device Sequence Number: 8871633
• 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: K151860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/12/2025

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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2020
• 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