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	High Sensing Threshold (2574); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
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 the m540 monitor has difficulties obtaining a nibp measurement with a neonatal patient.The device was replaced with another monitor to obtain a reading.There was no report of adverse patient impact.
Additional Manufacturer Narrative
The customer alleged that the m540 monitor repeatedly could not measure nibp and displayed asterisks and error messages.It was noted that the nibp starts, and the measurement immediately aborts.The customer stated that the observed error occurred more often in smaller and lighter patients under 500 grams, and that nibp measurement is delayed by hours.Additional information obtained through investigation confirmed that there was no adverse patient impact.The described event alleging that the device displayed 'cuff leak' and 'hose disconnected' error messages could not be confirmed with the information available.The logs were reviewed and showed that there was 'nibp measurement timeout' and 'nibp blocked line' messages on the date of the event.However, as no time of event was provided, it cannot be concluded which time the reported event took place.The software investigation determined that the observed m540 behavior was due to the m540 minimum pulse amplitudes not being met due to the physiological state of the patient.The m540 behaved as designed with no malfunction.A software enhancement to lower the m540 nibp minimum amplitude threshold will be available in future software versions for hardware revisions 24 and above.
Event or Problem Description
It was reported the m540 monitor has difficulties obtaining a nibp measurement with a neonatal patient.The device was replaced with another monitor to obtain a reading.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: 21494326
• Report Number: 1220063-2025-00017
• Device Sequence Number: 19832360
• Product Code: MHX
• UDI-Device Identifier: 04049098009751
• UDI-Public: (01)04049098009751(11)241129(93)MS26372-66
• 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): 05/09/2025

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: 02/20/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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