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

Medical Device Problem Codes	Device Sensing Problem (2917); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that several times that the automatic nibp measurement on the m540 monitor does not start.The "auto" field including the "progress bar" has suddenly disappeared.Four to five interval measurements work and then nothing more.This can only be remedied by putting the cockpit into standby and "enabling" it again.There was no report of adverse patient impact.
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported that several times that the automatic nibp (non-invasive blood pressure) measurement on the m540 monitor does not start.The "auto" field including the progress bar has suddenly disappeared.Four to five interval measurements work and then nothing more.This issue was resolved by putting the cockpit into standby and re-enabling it.No adverse patient impact was reported.
Additional Manufacturer Narrative
To troubleshoot the issue, the user restarted the m540 monitor, after which the behavior was resolved and did not recur.Log files and the date and time of the event were requested but not provided.Without this information, the reported behavior could not be confirmed, and a root cause could not be determined.Should additional information such as logfiles capturing the reported behavior be provided, a sub-investigation can be opened to further evaluate the reported device behavior.

• 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: 21582976
• Report Number: 1220063-2025-00020
• Device Sequence Number: 18460556
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)241126(17)250219(93)MS25510-79
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown