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	Failure to Select Signal (1582); Capturing Problem (2891); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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 nibp interval was unavailable at the local m540 monitor and the monitor was swapped out.There was a delay in patient care because of the reported event.A delay in patient care can result in adverse patient consequences.In this case, there was no report of adverse patient impact.
Event or Problem Description
It was reported that the non-invasive blood pressure (nibp) interval mode intermittently functioned as intended, and there was an instance when the interval time could not be changed on the infinity m540 and the infinity medical cockpit c700 while the equipment was in use with a patient.The user attempted to troubleshoot the issue by exchanging out the infinity m540 monitor, but the issue persisted.Although no adverse patient impact was reported, there was a delay in patient care as a result of this issue.
Additional Manufacturer Narrative
Additional information confirmed the interval was set to off when the issue was observed, and it was noted that the user was able to obtain nibp manually at time of the event.Draeger confirmed and reproduced the reported issue in a lab setting.It was verified that while an nibp measurement was in progress, if the interval was set to a value, then the interval could be changed, but when the interval was set to off, the interval value failed to change.These test results confirmed the reported issue of the nibp interval not changing when the interval value was set to off.In conclusion, it was determined this functionality for changing the nibp interval value was inconsistent in the infinity acute care systems (iacs) running the software vg7.1.1.Draeger has planned to address this behavior in a future software version.

• 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: 21741334
• Report Number: 1220063-2025-00026
• Device Sequence Number: 11764091
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)200701(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): 05/13/2025

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: 03/06/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2020
• 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