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

Catalog Number	MS20401
Medical Device Problem Codes	Communication or Transmission Problem (2896); Connection Problem (2900); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No additional information has been provided.A supplemental report will be submitted following the completion of the manufacturer's investigation.
Event or Problem Description
It was reported that the infinity m540 patient monitor lost communication with the dual hemo m-cable and the associated invasive pressure transducers during a surgical procedure with a patient.It was noted that the customer attempted to swap out the cables, but this did not resolve the reported problem.Eventually, the infinity m540 patient monitor was swapped out to resolve the issue.There was no interruption in patient care or adverse patient impact reported.
Event or Problem Description
It was reported that the infinity m540 patient monitor lost communication with the dual hemo m-cable and the associated invasive pressure transducers during a surgical procedure with a patient.It was noted that the customer attempted to swap out the cables, but this did not resolve the reported problem.Eventually, the infinity m540 patient monitor was swapped out to resolve the issue.There was no interruption in patient care or adverse patient impact reported.
Additional Manufacturer Narrative
The issue was resolved by the customer through replacement of the m540 monitor.No adverse patient impact was reported.The m540 device was inspected by draeger, and the log files were reviewed.No indication of device malfunction was found, and the issue could not be reproduced during testing.To support further investigation, draeger requested the m500 docking station and dual hemo cables from the customer; however, no response was received.Based on the available information, no device malfunction of the m540 was confirmed, but a root cause could not be determined.

• 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 ; 9784097390
• MDR Report Key: 22460871
• Report Number: 1220063-2025-00037
• Device Sequence Number: 12906306
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)230908(17)231018(93)MS25510-74
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: MS20401
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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