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

Catalog Number	MS25520
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Insufficient Information (4580)
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 that after moving a patient from induction to urology, the nibp (non--invasive blood pressure) could not be measured with the m540 monitor.The patient was cardiopulmonary stable and there was no adverse patient impact.
Event or Problem Description
It was reported that after moving a patient from induction to urology, the nibp (non--invasive blood pressure) could not be measured with the m540 monitor.The patient was cardiopulmonary stable and there was no adverse patient impact.
Additional Manufacturer Narrative
The cockpit logs provided for review showed nibp data import error messages.However, further investigation into the cockpit c700 logs provided no root cause for the messages.The m540 logs that were provided were determined to be the incorrect m540.The logs downloaded after the event were taken from the iacs, with an m540 docked.During investigation, it was determined that another m540 was in use during the event.When attempting to obtain the correct m540 logs, the logs for the date of the event had already been overwritten due to the device remaining in use.No root cause of the error messages could be determined from the cockpit logs, and as the m540 logs were unavailable, a root cause could not be determined.If the reported issue occurs again, another complaint will be opened to re-investigate.
Event or Problem Description
It was reported that after moving a patient from induction to urology, the nibp (non--invasive blood pressure) could not be measured with the m540 monitor.The patient was cardiopulmonary stable and there was no adverse patient impact.
Additional Manufacturer Narrative
The cockpit logs provided for review showed nibp data import error messages.However, further investigation into the cockpit c700 logs provided no root cause for the messages.The m540 logs that were provided were determined to be the incorrect m540.The logs downloaded after the event were taken from the iacs, with an m540 docked.During investigation, it was determined that another m540 was in use during the event.When attempting to obtain the correct m540 logs, the logs for the date of the event had already been overwritten due to the device remaining in use.No root cause of the error messages could be determined from the cockpit logs, and as the m540 logs were unavailable, a root cause could not be determined.As the m540 continued to be used, and it was further confirmed that the issue did not reoccur and a root cause could not be determined, the reported symptom may have been a temporary issue.Since the device has been back in use, no further issues have been reported.

• 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: 21480957
• Report Number: 1220063-2025-00016
• Device Sequence Number: 3995270
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)180620(93)MS25520-50
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2025

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: MS25520
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2018
• 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