MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number	MS20401
Medical Device Problem Codes	No Device Output (1435); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a disconnection between the cockpit and m540 monitor during patient use resulted in an interruption in live patient monitoring.There was no adverse patient impact.
Additional Manufacturer Narrative
Review of the logs provided showed that the timing between m540s and cockpits were not aligned.A signature entry following the timing discrepancies was identified.When this communication error occurs, the cockpit attempts to correct the issue and in the cases it cannot, as a result, the cockpit closes all communications to the m540.When this occurs, the m540 maintains monitoring capability as intended as a stand-alone patient monitor.Notably, discharging the patient from the m540 resolves the issue, re-establishes connection and the patient can be reassigned to the monitor.Attempts to reproduce the disconnect issue at draeger have been unsuccessful in a simulated clinical test setup.One of the affected m540s was returned to draeger for evaluation and no device malfunctions were identified.Though the specific root cause of the timing issue cannot be determined, draeger has identified an opportunity to develop software code changes that are intended to prevent the cockpit from disconnecting due to timing alignment issues, regardless of the cause, for a future software release.
Event or Problem Description
It was reported a disconnection between the cockpit and m540 monitor during patient use resulted in an interruption in live patient monitoring.There was no adverse patient impact.
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• 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: 21646318
• Report Number: 1220063-2025-00022
• Device Sequence Number: 7574234
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)180829(93)MS20401-29
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2018
• 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