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

Catalog Number	MS20401
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Tachycardia (2095); Insufficient Information (4580)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported that an infinity acute care system m540 monitor could not obtain blood pressure measurement on a neonatal patient.The users had to switch devices to then obtain a measurement.The administration of medication was delayed due to this issue.There was no report of adverse patient impact.
Additional Manufacturer Narrative
The logs were reviewed and confirmed that the device was issuing svt alarms and nibp alarms as reported.The instructions for use (ifu) claims that the nibp can be impacted by various patient conditions, including arrythmias.The customer should refer to the ifu for further information regarding patient preparation for nibp measurement.No further patient injury was reported, and the patient was discharged from the hospital.Based on the information provided, there was no device malfunction.
Event or Problem Description
It was reported that an infinity acute care system m540 monitor could not obtain blood pressure measurement on a neonatal patient.The users had to switch devices to then obtain a measurement.The administration of medication was delayed due to this issue.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: 21415342
• Report Number: 1220063-2025-00012
• Device Sequence Number: 9245217
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)210507(93)MS20401-30
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: MS20401
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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