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	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Draeger has started an investigation, a follow up report will be submitted upon completion.
Event or Problem Description
It was reported that the nibp (non-invasive blood pressure) measurement feature on the iacs (infinity acute care system) m540 patient monitor remained non-functional for neonates weighing less than 1000 grams.On (b)(6) 2025, 12:30 a neonate weighing 780 grams required continuous monitoring.Due to the inability to obtain nibp readings with the iacs, a philips monitor was used to ensure continuous measurement.On (b)(6) once the neonate¿s condition stabilized and vital signs improved, nibp measurements could again be performed using the iacs.No patient harm occurred during this period; however, the inability to measure nibp in extremely low-weight neonates presents a potential risk for delayed clinical intervention.
Event or Problem Description
It was reported that the nibp (non-invasive blood pressure) measurement feature on the iacs (infinity acute care system) m540 patient monitor remained non-functional for neonates weighing less than 1000 grams.On (b)(6) 2025, 12:30 a neonate weighing 780 grams required continuous monitoring.Due to the inability to obtain nibp readings with the iacs, a philips monitor was used to ensure continuous measurement.On (b)(6), once the neonate¿s condition stabilized and vital signs improved, nibp measurements could again be performed using the iacs.No patient harm occurred during this period; however, the inability to measure nibp in extremely low-weight neonates presents a potential risk for delayed clinical intervention.
Additional Manufacturer Narrative
A review of the logfiles from (b)(6) 2025 around 12:30 confirmed the reported event as the device issued many 'nibp out of range low' alarms starting at 12:43.The device alarmed as intended.Additionally, the log entries show most of measurements taken over the course of the following days were completed successfully, indicating overall device reliability and consistent monitoring intervals when the patient became stable.The logfiles did contain several technical alarms, such as intermittent "nibp cannot measure" and "nibp measurement timeout" events.These messages show there were instances where blood pressure measurements could not be obtained, likely due to patient movement, cuff issues, or transient physiological conditions.All observed events were resolved within minutes as evidenced by correlating "remove" log entries.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.

• 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: 23803326
• Report Number: 1220063-2025-00061
• Device Sequence Number: 7686102
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)221202(17)231031(93)MS20401
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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
• Patient Weight: 780 KG