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

Catalog Number	MS20401
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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 the m540 monitor is shutting down during a case.There was no report of adverse patient impact.The device was swapped with another m540 monitor.
Additional Manufacturer Narrative
The faulty m540 was inspected by the hospital biomed, and the issue was not reproducible.Multiple attempts were made to obtain additional information from the customer regarding the event.The customer confirmed that the unit was put back into use after the biomed inspection and no further issues were reported.The customer was unable to provide the correct log files.No further information was provided.The reported event could not be confirmed without the correct device logs.A root cause analysis could not be performed without the device logs.
Event or Problem Description
It was reported that the m540 monitor is shutting down during a case.There was no report of adverse patient impact.The device was swapped with another m540 monitor.

• 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: 21093733
• Report Number: 1220063-2025-00003
• Device Sequence Number: 21015729
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)240206(17)240930(93)MS20401-32
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2024
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown