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

Catalog Number	MS32504
Medical Device Problem Codes	Loss of Data (2903); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Draeger has attempted to retrieve the device logs for investigation, however the customer has declined the use of usb sticks to be plugged into their ics to retrieve the requested logs.Based on the information available we are unable to confirm the reported issue or determine a root cause.
Event or Problem Description
The customer reported that the (ics) infinity central station rebooted on its own.Approximately two hours later the staff noticed the trends and full disclosure were missing.In addition, it was reported that the associated bedside monitor is a (m300) telemetry.There was no report of adverse patient impact.
Additional Manufacturer Narrative
Draeger has attempted to retrieve the device logs for investigation, however the customer has declined the use of usb sticks to be plugged into their ics to retrieve the requested logs.Based on the information available we are unable to confirm the reported issue or determine a root cause.Correction to annex g code.
Event or Problem Description
The customer reported that the (ics) infinity central station rebooted on its own.Approximately two hours later the staff noticed the trends and full disclosure were missing.In addition, it was reported that the associated bedside monitor is a (m300) telemetry.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 ; 9784090504
• MDR Report Key: 21217447
• Report Number: 1220063-2025-00006
• Device Sequence Number: 11607514
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)190703(93)MS32504-11
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: MS32504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2024
• Supplement Date Received by Manufacturer: 12/28/2024
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2019
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown