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	Disconnection (1171); No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the c500 cockpit continually disconnected from the m540 and showed a blank screen during two operating procedures on (b)(6) 2024.The c500 cockpit screen would go entirely black for 5 seconds at a time.After the 5 seconds of a blank screen, the display would show an "m540 disconnected," message, followed by the monitored parameters eventually returning to the display.However, not all waveforms were visible when the parameters returned.The customer confirmed the m540 was not affected by this error on the c500, as it continued to monitor with all waveforms and parameters visible on the m540 screen.This infinity acute care system (iacs) was not monitored by a centralstation.The m500 charging pins were confirmed to have been intact and not damaged.It was noted that the c500 was mounted on an a500 perseus.The clinician attempted to resolve the issue by swapping out the m540 device, but the problem continued to occur with each new m540.The entire a500 perseus device was taken out of clinical use.
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 c500 cockpit continually disconnected from the m540 and showed a blank screen during two operating procedures on (b)(6) 2024.The c500 cockpit screen would go entirely black for 5 seconds at a time.After the 5 seconds of a blank screen, the display would show an "m540 disconnected," message, followed by the monitored parameters eventually returning to the display.However, not all waveforms were visible when the parameters returned.The customer confirmed the m540 was not affected by this error on the c500, as it continued to monitor with all waveforms and parameters visible on the m540 screen.This infinity acute care system (iacs) was not monitored by a centralstation.The m500 charging pins were confirmed to have been intact and not damaged.It was noted that the c500 was mounted on an a500 perseus.The clinician attempted to resolve the issue by swapping out the m540 device, but the problem continued to occur with each new m540.The entire a500 perseus device was taken out of clinical use.
Additional Manufacturer Narrative
The review of the logs provided confirmed one disconnection on the reported date of event.However, the customer reported multiple disconnects, which could not be confirmed.The incorrect m540 logs were provided for review.Draeger made multiple requests for the correct m540 logs, but they were not provided.With the limited information available, no device malfunction could be confirmed.

• 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 ; 9784090504
• MDR Report Key: 20965129
• Report Number: 1220063-2024-00135
• Device Sequence Number: 20948050
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)210517(93)MS20401-30
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 04/22/2025
• 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