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

Model Number	MS20401
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); No Audible Prompt/Feedback (2282); Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Draeger has started an investigation, a follow up report will be submitted upon completion.
Event or Problem Description
The customer reported the m540 monitor did not emit an audible warning signal, even though it had not been muted.The staff only became aware of the alarm because of the simultaneous visual signal.There was no adverse patient impact, as the alarm condition was detected in time.
Event or Problem Description
The customer reported the m540 monitor did not emit an audible warning signal, even though it had not been muted.The staff only became aware of the alarm because of the simultaneous visual signal.There was no adverse patient impact, as the alarm condition was detected in time.
Additional Manufacturer Narrative
The device was returned to the draeger repair bench for evaluation and the reported symptom was verified.Root cause was identified as a failed power board.The power board was replaced to resolve the issue, and the device was returned to the customer after passing all required 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: 24701071
• Report Number: 1220063-2026-00007
• Device Sequence Number: 10557720
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)230131(17)231130(93)MS20401-32
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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 Model 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): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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