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

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Connection Problem (2900); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an m540 had issues disconnecting at regular intervals.The customer did not state if the m540 or the cockpit had the following defects.The customer states that the reported device's parameters would zero for a short time, and then the screen would turn black and warn that it was disconnected from the m540.Then the device would then connect on its own.The reported disconnection would occur up to every 4 minutes for 20-30 seconds, taking the same amount of time each time.The medical technician attempted to restart all devices and remove the cables, which did not resolve the issue.The m540 was replaced several times.No adverse patient impact or death was reported.
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
The customer reported that an m540 had issues disconnecting at regular intervals.The customer did not state if the m540 or the cockpit had the following defects.The customer states that the reported device's parameters would zero for a short time, and then the screen would turn black and warn that it was disconnected from the m540.Then the device would then connect on its own.The reported disconnection would occur up to every 4 minutes for 20-30 seconds, taking the same amount of time each time.The medical technician attempted to restart all devices and remove the cables, which did not resolve the issue.The m540 was replaced several times.No adverse patient impact or death was reported.
Additional Manufacturer Narrative
The customer confirmed the issue was reproducible and noted the error was noticed prior to the software upgrade, but the issue occurred more frequently after the upgrade.The customer made multiple attempts to resolve the issue with no success.Draeger service was contacted, and they reviewed the provided log files.It was noticed in these logs that the m500 was running firmware (fw) version 4.2 and not fw5.0.Since the iacs was running vg8, it would have been expected that the m500 be running fw5.After this discovery, the customer swapped the m500 with a 5.0 version and the reported issue was resolved.In conclusion, the m540 disconnection issue was confirmed to be related to the m500 firmware not being up to date.Swapping the m500 to an m500 with the latest version resolved the reported issue.No further concerns from the customer have been reported.The vg 8 software installation instructions include a note that it is required for all the following components be upgraded in order for vg8 functionality to be realized: m500, m540, c700/c500 cockpit.The reason that the m500 was not upgraded during the installation of vg8 was not confirmed.These instructions have been sent to the complainant to inform them of this process requirement.This is considered to be a malfunction in servicing, the cause of the servicing could not be determined.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• 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 ; 2156602400
• MDR Report Key: 20371222
• Report Number: 1220063-2024-00115
• Device Sequence Number: 20528988
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)120710(93)MS25643-02
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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 Model Number: N/A
• Device Catalogue Number: MS26196
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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