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

Catalog Number	MK32700
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the infinity central station (ics) and infinity acute care system (iacs) intermittently displayed st parameters as.No adverse patient impact was reported.
Additional Manufacturer Narrative
Draeger reviewed the logs and confirmed the reported event.The log review found multiple ecg alarms, including ¿ecg artifact,¿ ¿arr cannot learn lead ii,¿ and ¿cannot analyze st.¿ the instruction for use provides guidance on how to interpret parameter readings of and provides users with definitions of the alarm conditions.These alarms were indicative of problems with the quality of the ecg in which the monitor was unable to calculate the st values.If the monitor can¿t calculate st values, it would be expected for the related parameters to be displayed as or to have continuously changed.The quality of ecg can be affected by a variety of factors, and in this case, it was affected by the neutral electrode switching back and forth between leads and due to patient movement.When this behavior occurred, the st waveform set to zero for about 4 seconds, and the waveform briefly went flat.This behavior known as autoblock has been planned to be improved by draeger for a future software release.

• 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: 21732120
• Report Number: 1220063-2025-00024
• Device Sequence Number: 4222896
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)201019(93)MK32700-03
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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: MK32700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown