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	Unable to Obtain Readings (1516); Device Sensing Problem (2917)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2025
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 a blood pressure measurement could not be obtained on a patient with the m540 monitor.Another monitor was used to obtain the reading.There was no report of adverse patient involvement.
Event or Problem Description
The customer reported that the infinity acute care system (iacs) m540 monitor was unable to obtain a non-invasive blood pressure (nibp) measurement on a critical patient in the nicu throughout the day on (b)(6) , to (b)(6) 2025.The customer reported that they were able to obtain a nibp measurement on a delta monitor, but that administration of inotrope medication had been delayed for 15-20 minutes.The customer confirmed there was no patient injury.
Additional Manufacturer Narrative
Review of the reported event confirmed that the m540 monitor, and the delta monitor behaved as designed.The reported non-invasive blood pressure (nibp) values obtained by the delta reflects the devices' expected behavior accurately, and the information available does not indicate a device malfunction.Further technical investigation determine that the m540 has a higher pulse amplitude requirement than the delta.The m540¿s pulse amplitude threshold was set to be higher than the delta due to the different operational amplifier (op amp).This op amp was replaced in m540 hardware revision 24 (hw rev.24).Through simulation testing with the m540 rev 24., it was determined that the m540 was able to reliably measure to 4% pulse amplitude, similar to the delta.Once the pulse amplitude threshold is changed and implemented, the m540 will meet customer expectations without affecting accuracy.The change will be implemented and available in a future software release.The root cause of the reported inability to measure nibp in critical neonates is due to the m540¿s higher pulse amplitude threshold requirements.The investigation concluded that there was no device malfunction, and that the m540 nibp behavior meets all specifications, standards, and instructions for use statements (ifu).The iacs ifu states that the nibp signal can decrease, or the measurement may fail under certain patient conditions including weak or irregular pulses.The monitor may display 'nibp cannot measure' if the pulse profile is too poor to establish a reliable measurement.The device may also display 'nibp mean only' is the pulse amplitude is too small or too high.For both alarm messages, the ifu recommends checking the patient and to provide treatment if necessary.The customer confirmed that they received both 'nibp cannot measure' and 'nibp mean only' messages from the iacs during the reported event.

• 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: 21561113
• Report Number: 1220063-2025-00019
• Device Sequence Number: 9601558
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)201203(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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/04/2025
• 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