MAUDE Adverse Event Report: Draeger Medical Systems, Inc Infinity Acute Care System (M540); Physiologic monitoring system, single-patient

Catalog Number	MS20401
Medical Device Problem Codes	Device Alarm System (1012); Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on the night of friday, (b)(6), between 3:00 a.M.And 5:00 a.M., a patient died without any event being reported to the ics monitoring center "[infinity central station (ics)]".The nurses checked the patient¿s vital signs around 3:00 a.M.And then returned to the patient around 5:00 a.M., at which time they confirmed the patient¿s death.According to the available information, no alarm was triggered or displayed on the monitoring console "[infinity acute care system (iacs)]" during that time.
Additional Manufacturer Narrative
Device logs were provided.Additional information was requested including ics full disclosure files or any waveform strips or images available, arr lead/s selection, qrs threshold setting (low or high), condition the patient was being monitored for.However, this information was not provided.The involved iacs and ics were tested on site by a draeger technician and the hospital biomed.No malfunctions were identified.Review of the iacs primary monitoring system logs shows that the system was in privacy mode during the time of the event.Activating privacy mode has the following effect: ¿ all patient data are removed from the cockpit and the m540 displays but continue to be displayed at the ics.¿ the alarm bar is deactivated.¿ acoustic alarm signals are only provided at the ics.¿ the message privacy ¿ touch screen to resume monitoring is displayed in the center of the screen.Review of the infinity central station (ics) log show that alarms were provided at the ics during the specified time including ecg leads disconnected, ecg artifacts and bp < 90.None of these alarms were acknowledged.Note that if there is no ecg signal, arrythmia monitoring is not possible.The technical alarms are provided to prompt the staff to check the patient and resolve the lead disconnection/artifact issues identified.No draeger device malfunctions were identified.This is consistent with a use issue regarding expected alarms during the event.This information was provided to the complainant.

• 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 ; +1(978)409-7390
• MDR Report Key: 50133037
• Report Number: 1220063-2026-00022
• Device Sequence Number: 20243255
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)161014(93)MS20401-26
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MS20401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Male