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

Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Codes	Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Draeger has started an investigation into this complaint, a follow up report will be submitted upon completion of investigation.
Event or Problem Description
It was reported on (b)(6) 2025, at approximately 04:18 a.M., a ventricular tachycardia (vt) alarm lasting approximately nine minutes was not displayed at the central monitoring station.The patient parameters, including electrocardiogram (ecg) values, were transmitted and displayed correctly at the central station; however, no alarm notification was generated or displayed during the reported timeframe.There was no adverse patient impact.
Additional Manufacturer Narrative
Ics and m540 logs were provided.The m540 logs provided did not include the event log file and the alarm history logs were overwritten and therefore did not provide the alarms generated during the reported event time.The ics alarm history logs were reviewed, and it was confirmed that no vt alarms were received from m540 device identified for the date/time identified.Additional information including the m540 event log, what lead/s were selected for arrhythmia detection (ecg strips for the lead/s selected) & the vt alarm rate/count settings, however this information was not provided.Due to insufficient information, a root cause could not be determined.
Event or Problem Description
It was reported on (b)(6) 2025, at approximately 04:18 a.M., a ventricular tachycardia (vt) alarm lasting approximately nine minutes was not displayed at the central monitoring station.The patient parameters, including electrocardiogram (ecg) values, were transmitted and displayed correctly at the central station; however, no alarm notification was generated or displayed during the reported timeframe.There was no adverse patient impact.

• Brand Name: INFINITY CENTRAL STATION
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• 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: 23632746
• Report Number: 1220063-2025-00058
• Device Sequence Number: 9381577
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)190402(91)N/A(93)MS20401-29
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2019
• 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