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

Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Draeger has started an investigation into this issue.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported the m540 patient monitor and c500 cockpit display powered off during a case.The doctor had to physically press the power buttons to turn back on.There was no report of adverse patient impact.
Additional Manufacturer Narrative
It was further noted that the issue occurred in the electrosurgical unit (esu) when the cauterizing tool coagulation button was pressed.The infinity acute care system (iacs) cockpit and m540 logs were provided which confirmed the shutdowns but could not specify the cause.The revision of system cable (which provides the connection between the m540 and the cockpit through the m500 docking station) in use during the event was requested but could not be confirmed.The customer stated that it was unknown if the involved system cable was of the latest version and the issue has not recured.The current revisions of system cables contain enhanced shielding to preserve functionality during esu use.It was recommended they check all their iacs system cables to ensure they have the latest version with the gray dot.If they do not, it is advised that they replace them to ensure the best shielding from esu devices - specifically in the operating rooms where the cauterizing equipment is typically in use.This as consistent with the use of the older version of the system cable (prior to enhanced shielding) with an esu device.If the issue occurs again and the system cable in use is confirmed to be of a revision including the enhanced shielding, another complaint will be generated.
Event or Problem Description
It was reported the m540 patient monitor and c500 cockpit display powered off during a case.The doctor had to physically press the power buttons to turn back on.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: 24393249
• Report Number: 1220063-2026-00003
• Device Sequence Number: 10504654
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)200108(91)N/A(93)MS20401-30
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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