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

Catalog Number	MS25510
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported to draeger that the iacs screen froze and rebooted, and that the restart was not reproducible.The report also stated that the recorder could not be used before or after the iacs rebooted, and that there was an unspecified noise before the device rebooted.The device was replaced but no information stating which device was replaced was provided.Additional information later provided stated that the m540 rebooted for 1-2 minutes on a patient under surgery with no alarm.There was no report of adverse patient impact or a delay in treatment.Additional information regarding the device, the device logs, and patient condition were requested multiple times but not provided.No root cause or further analysis could be conducted, as no additional information was received.The device remains in use at the customer site.
Event or Problem Description
It was reported that the iacs c500 and m540 screen froze and went black, then restart occurred.After that, there is no reproducibility of restart.However, the recorder could not be used, and no output was possible even before the restart occurred.Also, sometimes noise occurred even before the restart occurred.The affected c500 is draeger repair substitute device.It was replaced with another repair substitute device.It seems m540 also restarted at the same time or with a short time lag.

• 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: 20174048
• Report Number: 1220063-2024-00102
• Device Sequence Number: 15204346
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(93)MS25510
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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: MS25510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 09/09/2024
• 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