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

Medical Device Problem Codes	Disconnection (1171); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the m540 and c700 disconnected and the m540 rebooted on its own.The reboot of the m540 occurred during use with a patient but no adverse patient impact was reported.The device alarmed appropriately to alert the user of the issue.
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Additional Manufacturer Narrative
Initial information available determines that the original m540 which restarted during use when the miscommunication happened was not available.The customer staff stated that they were not able to locate the m540, as it been put back into use, and that the serial number was unknown.The log review determined that the original m540 serial number in use before the replacement had been m540 sn: (b)(6).Service records determined that the m540 had been serviced and reset to factory settings by a draeger technician on (b)(6) 2024, and the issue was resolved.Our service records state the customer profiles were added successfully, relevant test procedures and device checks performed as applicable and are successful and within tolerance values.The device was handed over to customer in operable condition.Upon review, the logs showed 356 disconnects at the iacs between on (b)(6) 2024.It was determined that none of the log disconnect entries were unintentional device behavior.However, the cause for the frequent disconnects cannot be determined.As the original m540 was replaced and was not identified by users, and was reset to factory settings during service, the logs were not pulled for review, and therefore the alleged m540 reboot could not be confirmed.Upon request, further patient information was not available.The complaint report stated that there had been no patient injury, and there was no of any delay to patient care.The m540s in the or at the customer site, including the m540 sn: (b)(6) reported to be used for testing by the biomedical engineer after the reported event, were reset to factory default to mitigate any reoccurrence on (b)(6) 2024.As of on (b)(6) 2025, there has been no reoccurrence at the customer site.
Event or Problem Description
It was reported that the m540 and c700 disconnected and the m540 rebooted on its own.The reboot of the m540 occurred during use with a patient but no adverse patient impact was reported.The device alarmed appropriately to alert the user of the issue.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• 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: 20581907
• Report Number: 1220063-2024-00127
• Device Sequence Number: 12905387
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)231124(93)MS25520-71
• 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): 04/04/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown