MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGIC MONITORING SYSTEM

Model Number	N/A
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); Device Handling Problem (3265)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	10/25/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
On october 30th, the fse received a service call to check the alarms at the infinity control center (ics).While on site the customer informed the fse that a patient had suffered a cardiac incident on (b)(6) around 5:30.The patient was found in their room with the m300 alarming, and was transferred to the cardiology intensive care unit, there the patient passed away.The customer reported that the m300 did not alarm acoustically at the ics, and suspected that some of the alarms were not working properly.
Event or Problem Description
On october 30th, the fse received a service call to check the alarms at the infinity control center (ics).While on site the customer informed the fse that a patient had suffered a cardiac incident on october 25th around 5:30.The patient was found in their room with the m300 alarming, and was transferred to the cardiology intensive care unit, there the patient passed away.The customer reported that the m300 did not alarm acoustically at the ics, and suspected that some of the alarm were not working properly.
Additional Manufacturer Narrative
The draeger technician tested several m300s and confirmed that alarms were working as intended.The technician retrieved the ics logs.The customer could not identify which m300 was involved.The ics logs were reviewed by escalation support and confirmed that the ics was alarming as designed.During investigation, the customer confirmed that the patient had become unwell during the night, and that the patient condition had been reported to the nurse.The nurse was present with the patient and communicated with the intensive care unit, who saw a mirrored image of the monitoring care unit and did not see any cardiological abnormalities.This caused the report that the control center did not raise the alarm even though the patient is very unwell.The staff then decided to transfer patient to the intensive care unit, where the patient was then monitored with a different monitor before later passing away.The customer confirmed to the draeger technician that the telemetry system had nothing to do with the patient incident.Additional information confirmed that the names of the patient fields before the event had been assigned numbers.The layout of the ics had been configured to 4 patient beds, and these 4 numbers had been mixed up and misinterpreted by some users, resulting in the alleged missed alarms at the ics.To avoid this in the future, the patient fields were re-labeled with the ward name and sequential number (e.G.A3_1.), and the control center of unit a3 was reconfigured with the correct beds, and the central station view (layout) was configured to 4 views at the request of the station.

• Brand Name: INFINITY CENTRAL STATION
• 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 ; 9784828529
• MDR Report Key: 20629771
• Report Number: 1220063-2024-00129
• Device Sequence Number: 7928805
• Product Code: MHX
• UDI-Device Identifier: 04049098004190
• UDI-Public: (01)04049098004190(11)080923(93)MS18500-08
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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 Model Number: N/A
• Device Catalogue Number: MS24215
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2008
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown