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

Catalog Number	MS32504
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	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Draeger has started an investigation, a follow up report will be submitted upon completion.
Event or Problem Description
It was reported that the m300 telemetry monitor was discharging on its own without any user interaction.
Additional Manufacturer Narrative
Investigation of the device log files determined the failure of the infinity m300 to recover its network connection following an offline state was due to a software timing issue within the device's network management system.When the m300 went offline, it would be expected that in order to reconnect, it needed to establish a secure connection and identify the appropriate bed label.In this case, these tasks occurred simultaneously, and the software mishandled the event sequence.This failure in the network state machine resulted in a premature termination of the wireless session, explaining the unexpected discharge observed at the ics.The identified cause will be addressed in a future software release.
Event or Problem Description
It was reported that the m300 telemetry monitor was discharging on its own without any user interaction.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): OHAYO DAIRY PRODUCTS CO., LTD.; kamizawa 1011-2; hokota-shi,; ibaraki 311-2 111; JA 311-2111
• Manufacturer Contact: kamizawa 1011-2; hokota-shi,; ibaraki 311-2-111 ; 9784097390
• MDR Report Key: 23510112
• Report Number: 1220063-2025-00057
• Device Sequence Number: 9954970
• Product Code: MHX
• UDI-Device Identifier: 04049098002035
• UDI-Public: (01)04049098002035(11)231016(91)VG2.4(93)MS26076-34
• 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): 05/06/2026

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: MS32504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2017
• 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