MAUDE Adverse Event Report: Draeger Medical Systems, Inc Infinity Acute Care System (M540); Physiologic monitoring system, single-patient

Catalog Number	MS25510
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, on the infinity central station, a patient's systolic arterial pressure (art) value of 70 mmhg was displayed while the low alarm threshold was configured at 75 mmhg.Despite the displayed value being below the configured alarm limit, no alarm was generated by the central station.No adverse patient effects, injury, or deterioration in clinical condition were reported.The device remained in clinical use.Subsequent on-site evaluation by dräger confirmed that the alarm function was operational during testing.The cause of the reported alarm behavior is under investigation.
Additional Manufacturer Narrative
Draeger is currently investigating this reported issue, a follow up report will be submitted upon completion.

• 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
• MDR Report Key: 50802993
• Report Number: 1220063-2026-00024
• Device Sequence Number: 21468751
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)200428(17)200928(93)MS25510-64
• 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
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: MS25510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown