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

Model Number	N/A
Medical Device Problem Codes	No Device Output (1435); Self-Activation or Keying (1557); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the m540 went into standby mode while on a patient without interaction in the presence of two users.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 the m540 went into standby mode while on a patient without interaction in the presence of two users.No adverse patient impact or death was reported.
Additional Manufacturer Narrative
Although the logs could not confirm either a user or device error, the device was returned to the customer without receiving servicing per the customer request.The fse reconfigured the set-up of keys on all m540s in the ward in agreement with the users.The m540 key with the original standby function was reconfigured so that the standby command can only be executed via the iacs cockpits.Since this action was performed, there have been no new occurrences of this phenomenon reported by the customer.
Additional Manufacturer Narrative
The m540 was returned to draeger for evaluation.The reported issue could not be reproduced, as a precaution, based on the reported symptom, it was recommended the bezel assembly be replaced.The device was returned to the customer without receiving servicing per the customer request, and the site deactivated the standby key function so that the standby command can only be executed via the iacs cockpit.Since this action was performed, there have been no new occurrences of this phenomenon reported by the customer.Draeger reviewed the logs and concluded that the initial m540 logs did not include the reported time of event.On march 17th 2025, additional logs were provided for analysis.The c500 cockpit logs show that the iacs was put into standby mode from the cockpit on the reported date of event (15:07 and 15:08 on september 26th).The iacs was removed from standby almost immediately for the first instance, at 15:07.When the iacs was put into standby mode at 15:08, it remained in standby until 15:18.The field service engineer (fse) confirmed that there was no adverse patient impact.The log evidence confirms that there was no device malfunction, as the device was put into standby mode at the cockpit by the user.
Event or Problem Description
The customer reported that the m540 went into standby mode while on a patient without interaction in the presence of two users.No adverse patient impact or death was reported.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• 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: 20407893
• Report Number: 1220063-2024-00118
• Device Sequence Number: 12367904
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)200520(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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 03/13/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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
• Patient Sex: Unknown