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

Catalog Number	MS20401
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
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 c700 cockpit rebooted losing connection to the (ics) infinity central station.The staff reported it took about two minutes to come back online.The m540 bedside monitor also froze and needed to be restarted.The c700 shutdown again after the restart.The staff performed a hard shut down and restart, which has resolved the issue there was no report of adverse patient impact.
Event or Problem Description
It was reported that the c700 cockpit rebooted losing connection to the (ics) infinity central station.The staff reported it took about two minutes to come back online.The m540 bedside monitor also froze and needed to be restarted.The c700 shutdown again after the restart.The staff performed a hard shut down and restart, which has resolved the issue there was no report of adverse patient impact.
Additional Manufacturer Narrative
The infinity acute care system (iacs) cockpit logs provided were reviewed and show a user-initiated shutdown at 10:42 and that the device was in standby mode from 10:46 to 15:17 on (b)(6) 2024, but there was no reboot entries identified for either the cockpit or the associated m540.It was confirmed that the correct bed logs were received, and the correct date of event was provided ((b)(6) 2024 at 15:17).The involved m540 patient monitor was returned to draeger for evaluation and the reported freeze could not be reproduced.As a precaution the main board was replaced, and the device was returned to the customer.No further issues have been reported.As the reported reboot and freeze could not be verified, no root cause could be determined.

• 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: 21219563
• Report Number: 1220063-2025-00007
• Device Sequence Number: 14332139
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)220908(93)MS20401-32
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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