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

Catalog Number	MS20401
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Codes	Elevated ketones/Diabetic Ketoacidosis (2364); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
A diabetic patient was admitted with hyperglycemia and taken to the operating room for a right foot wound debridement.The procedure was completed, but upon reversal of anesthesia, the patient did not respond.Resuscitation efforts were performed but were unsuccessful, and the patient passed away.The customer reported that the hr (heart rate) waveform was visible on the m540 patient monitor, but no hr values were displayed.Additionally, hr values were dashed out on the printouts.Follow-up inspection (july 11, 2025): a site visit was conducted for inspection and error analysis.During the visit, the monitor filter setting was corrected for use in an electrical surgical environment from 'monitor' to 'esu'(electrical surgical unit), resolving the issue with missing hr values.Hr values appeared on the monitor and were correctly printed.The patient monitor was tested on-site with the customer and successfully read nibp and spo2 data throughout the test.The data was printed correctly, confirming normal device functionality.
Additional Manufacturer Narrative
This investigation is ongoing as of july 31st, 2025.A follow up report will be submitted upon completion.
Event or Problem Description
A diabetic patient was admitted with hyperglycemia and taken to the operating room for a right foot wound debridement.The procedure was completed, but upon reversal of anesthesia, the patient did not respond.Resuscitation efforts were performed but were unsuccessful, and the patient passed away.The customer reported that the hr (heart rate) waveform was visible on the m540 patient monitor, but no hr values were displayed.Additionally, hr values were dashed out on the printouts.Follow-up inspection (july 11, 2025): a site visit was conducted for inspection and error analysis.During the visit, the monitor filter setting was corrected for use in an electrical surgical environment from 'monitor' to 'esu'(electrical surgical unit), resolving the issue with missing hr values.Hr values appeared on the monitor and were correctly printed.The patient monitor was tested on-site with the customer and successfully read nibp and spo2 data throughout the test.The data was printed correctly, confirming normal device functionality.
Event or Problem Description
A diabetic patient was admitted with hyperglycemia and taken to the operating room for a right foot wound debridement.The procedure was completed, but upon reversal of anesthesia, the patient did not respond.Resuscitation efforts were performed but were unsuccessful, and the patient passed away.The customer reported that the hr (heart rate) waveform was visible on the m540 patient monitor, but no hr values were displayed.Additionally, hr values were dashed out on the printouts.Follow-up inspection ((b)(6) 2025): a site visit was conducted for inspection and error analysis.During the visit, the monitor filter setting was corrected for use in an electrical surgical environment from 'monitor' to 'esu'(electrical surgical unit), resolving the issue with missing hr values.Hr values appeared on the monitor and were correctly printed.The patient monitor was tested on-site with the customer and successfully read nibp and spo2 data throughout the test.The data was printed correctly, confirming normal device functionality.
Additional Manufacturer Narrative
The initial incident report stated that the patient¿s death was due to abnormal vital signs not being addressed in time.However, further clarification confirmed that the customer did not attribute the patient¿s death to the device¿s behavior.Review of the report confirmed missing hr, nibp, and spo2 values during device use.The device logs showed alarm messages were generated for all missing parameters.These alarms corresponded to conditions that prevented parameter values from displaying.All alarms are associated with troubleshooting guidance in the instructions for use (ifu).Improper patient preparation (e.G., spo2 sensor placement, ecg lead/electrode setup, nibp configuration) or failure to address alarms can result in persistent alarm conditions and unavailable parameter values.Based on the investigation, no device malfunction was identified.The issue was resolved through proper configuration, and the device functioned as intended during follow-up testing.

• 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: 22592384
• Report Number: 1220063-2025-00042
• Device Sequence Number: 9128916
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)180201(93)MS25510-46
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/16/2025

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?: 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: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017; 09/16/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 07/31/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2017
• 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