MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGICAL MONITORING SYSTEMS

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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 m540 monitor disconnected from the infinity medical cockpit c500 during a patient cardiac procedure and the m540 monitor was swapped out as a result.Although an interruption in patient monitoring occurred, no adverse patient impact was reported.
Additional Manufacturer Narrative
A draeger technician went to the facility to retrieve the cockpit and the m540 logs for the date and time of event.The log analysis confirmed the disconnect, but the exact root cause could not be identified.The entire iacs system was requested with both the c500 and the m540 for analysis.The iacs system was connected to the draeger internal network for testing and no observable disconnect occurred in the two months running an ecg and waveform simulation.The customer was sent a replacement iacs system which was confirmed to be working according to manufacturer's specifications.
Event or Problem Description
It was reported that the infinity m540 monitor disconnected from the infinity medical cockpit c500 during a patient cardiac procedure and the m540 monitor was swapped out as a result.Although an interruption in patient monitoring occurred, no adverse patient impact was reported.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• 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: 21762175
• Report Number: 1220063-2025-00027
• Device Sequence Number: 8490453
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)240118(17)240930(93)MS20401-32
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: MS20401
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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