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

Catalog Number	MS25520
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	12/17/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported a patient was found unconscious on the floor and not connected to the infinity acute care system m540 patient monitor.At the time the patient was discovered, no alarms had been triggered by the device.Clinical staff-initiated resuscitation measures immediately.Despite continued medical intervention, the patient was subsequently pronounced deceased.
Additional Manufacturer Narrative
Draeger has started an investigation, a follow up report will be submitted upon completion.
Event or Problem Description
It was reported a patient was found unconscious on the floor and not connected to the infinity acute care system m540 patient monitor.At the time the patient was discovered, no alarms had been triggered by the device.Clinical staff-initiated resuscitation measures immediately.Despite continued medical intervention, the patient was subsequently pronounced deceased.
Additional Manufacturer Narrative
This investigation is ongoing, a follow up report will be submitted upon completion.
Event or Problem Description
It was reported a patient was found unconscious on the floor and not connected to the infinity acute care system m540 patient monitor.At the time the patient was discovered, no alarms had been triggered by the device.Clinical staff-initiated resuscitation measures immediately.Despite continued medical intervention, the patient was subsequently pronounced deceased.
Additional Manufacturer Narrative
During a follow-up visit, dräger personnel assessed the situation onsite.It was observed that the patient had an ecg cable properly connected to the electrodes on the chest; however, the disconnection occurred at the m540 monitor interface.Infinity central station (ics) logs were requested but did not cover the date of the reported event.Although the local dräger team indicated they were able to reproduce the issue during their site visit, no supporting evidence (e.G., video recordings or m540 device logs) was provided.Additionally, the serial number of the device used during this reproduction testing was not documented.The device and cables involved were not removed from clinical use following the reported failure.Independent testing was conducted using an m540 device running software version vg7.1.1, along with the following accessories: mp05115 (ecg 6-lead extension cable, 2 m), mp03404 (ecg 5-lead single-patient cable, aha, 1.5 m).Testing confirmed that when the ecg leads were disconnected at the m540 monitor, an ¿ecg unplugged¿ alarm was appropriately generated.Due to the absence of m540 device logs, lack of the involved device serial number, and unavailability of test data from the reported equipment (which remained in service), further investigation could not be performed.As a result, the reported issue could not be verified, and a root cause could not be determined.The customer has been advised that, should the issue recur, the device and associated cables should be immediately removed from service.Additionally, they should collect all relevant logs and submit a complaint to enable thorough investigation.

• 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: 24742036
• Report Number: 1220063-2026-00008
• Device Sequence Number: 8780348
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)231220(17)240420(93)MS25520-71
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MS25520
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 05/21/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/07/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown