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	Low Oxygen Saturation (2477)
Date of Event	02/27/2026
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
It was reported that the infinity acute care system (m540) patient monitor did not alarm for low spo2.There was no report of adverse patient impact.
Additional Manufacturer Narrative
The m540 was replaced to resolve the issue.The involved m54 was returned to draeger for evaluation and the reported issue could not be reproduced, no malfunctions were identified.M540 logs were provided but did not cover the date of the event.Screenshots were provided of the spo2 alarm settings.A video was provided confirming the reported issue.However, the device settings and video provided did not cover the nibp/spo2 interlock mode setting (when this feature is activated, all spo2 alarms are deactivated during an active non-invasive blood pressure measurement).Additional information was requested, including the nibp/spo2 interlock mode setting and nibp/spo2 trend data, but this information was not provided.Therefore, root cause cannot be identified.
Event or Problem Description
It was reported that the infinity acute care system (m540) patient monitor did not alarm for low spo2.There was no report of adverse patient impact.

• 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: 24533702
• Report Number: 1220063-2026-00005
• Device Sequence Number: 8895435
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)201113(17)210125(93)MS25520-63
• 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): 04/28/2026

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 Catalogue Number: MS25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2020
• 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