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

Model Number	MS20401
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an intermittent inability to obtain (nibp) non-invasive blood pressure measurements with the m540 patient monitor on a critically ill infant.Initially, nibp measurements were successful during treatment in the resuscitation unit and on the ward.Approximately 4 hours after birth (around 4:00 p.M.), only mean arterial pressure (mad) readings were possible.After an additional 2 hours (around 6:00 p.M.), no measurements could be obtained.Normal nibp measurement resumed approximately 7 hours later (around 1:00 a.M.) in this case there was no adverse patient impact.However, the inability to obtain the desired parameter reading using the infinity acute care system on a critical patient has the potential to cause or contribute to a death or serious injury if this malfunction were to recur.
Additional Manufacturer Narrative
Draeger has started an investigation, a follow up report will be submitted upon completion.
Additional Manufacturer Narrative
A review of the logfiles confirmed the reported event.The logfiles showed nibp measurements were successful following 12:00pm, but issues obtaining measurements did occur around 4:00pm and 6:00pm, as reported.The notable technical issues observed were mainly intermittent "nibp cannot measure" and "nibp measurement timeout" events which occurred during the afternoon and evening of (b)(6) 2025 and (b)(6) 2025.The device alarmed as intended.These events reflected episodes where measurements could not be obtained, likely due to patient movement, cuff issues, or transient physiological conditions.These events were automatically resolved within minutes as evidenced by correlating "remove" log entries.Most of the remaining log entries indicated successful, periodic blood pressure measurement cycles and normal device function, as shown through "nibp deflation done" and "mc_input_int_meas_complete." the instruction for use (ifu) tells users that weak or irregular pulses, patient movement, tremors, or respiratory artifacts can affect the accuracy of non-invasive blood pressure measurements and even cause them to fail.Before applying the cuff, users are advised to read the non-invasive blood pressure precautions.It is recommended that the cuff is not applied to a limb that is already used for other measurements and other patient connections should not interfere with each other.In conclusion, a review of the available information confirmed the device operated as expected and there was no evidence of a device malfunction or critical patient risk.
Event or Problem Description
It was reported that there was an intermittent inability to obtain (nibp) non-invasive blood pressure measurements with the m540 patient monitor on a critically ill infant.Initially, nibp measurements were successful during treatment in the resuscitation unit and on the ward.Approximately 4 hours after birth (around 4:00 p.M.), only mean arterial pressure (mad) readings were possible.After an additional 2 hours (around 6:00 p.M.), no measurements could be obtained.Normal nibp measurement resumed approximately 7 hours later (around 1:00 a.M.) in this case there was no adverse patient impact.However, the inability to obtain the desired parameter reading using the infinity acute care system on a critical patient has the potential to cause or contribute to a death or serious injury if this malfunction were to recur.

• 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: 23818274
• Report Number: 1220063-2025-00063
• Device Sequence Number: 10098393
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)221205(17)231031(93)MS20401-32
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/10/2026

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 Model Number: MS20401
• Device Catalogue Number: MS20401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 12/05/2022
• 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.; N/A.
• Patient Sex: Unknown