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

Catalog Number	MU25520
Medical Device Problem Codes	Unintended System Motion (1430); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the monitor kept going into stand-by mode while monitoring the patient while the patient was being prepper for anesthesia.The complaint form states that "the patient was on the table and had to be bagged", and also stated no reported injury.No patient death reported.
Additional Manufacturer Narrative
The initial udi and serial number for the reported device was incorrect.This follow up is to correct that information, and does not supply any additional investigation results at the time of this submission.
Event or Problem Description
The customer reported that the monitor kept going into stand-by mode while monitoring the patient while the patient was being prepper for anesthesia.The complaint form states that "the patient was on the table and had to be bagged", and also stated no reported injury.No patient death reported.
Additional Manufacturer Narrative
A complaint was submitted where it was reported that iacs monitor (m540) continued to go into standby mode during patient preparation for anesthesia.The user attempted to replace the m540 but the 'standby' problem persisted.A new anesthetic cart with new monitoring equipment was used to continue the case which was successful without any further issues.There was no adverse effect to the patient as a result of replacing the new monitoring equipment.Draeger technical support analyzed the logs and confirmed that the m540 went into 'standby' mode periodically, but it was very intermittent.This was communicated to the biomed at the customer's site where he performed an evaluation on the suspected m540.The biomed confirmed that the 'standby' button could be activated by pressing the m540 bezel case adjacent to the 'standby' key.The m540 bezel case was replaced, and the device ran for several hours with no failures found.The root cause of the m540 issue was determined to be a damaged bezel case.Replacing the old case with a new one resolved the reported issue.No further problems have been reported.
Event or Problem Description
The customer reported that the monitor kept going into stand-by mode while monitoring the patient while the patient was being prepper for anesthesia.The complaint form states that "the patient was on the table and had to be bagged", and also stated no reported injury.No patient death reported.

• 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: 19928529
• Report Number: 1220063-2024-00098
• Device Sequence Number: 18163462
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)160707(93)MS25520-40
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MU25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 09/18/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/08/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown