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

Catalog Number	MS26800
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the telemetry monitor did not alarm for a short ventricular tachycardiac event that lasted 9 beats while the alarm was set to medium.The event was shown to be stored as an event at the ics.The arrythmia was witnessed by the staff present at the bedside.Additionally, the customer reported that patient information was missing, but did not confirm what patient information.No patient harm or adverse patient impact was reported.Since the reported malfunction, the device has correctly alarmed.
Additional Manufacturer Narrative
Multiple requests were made requesting the m300 device information, the logs for the date of the event, and confirmation of the device alarming for a new event however a response was received stating that further information was available.The draeger product management team confirmed the reported issue to be an algorithm limitation with the m300 sw version that the customer was running.The root cause is that one of the beat classification buffers is not updating once the third questionable beat is matched to a new ventricular template.According to product management, the enhanced software to vg3.0.1 for the m300 was available to the customer on november 8th 2024 and drager is working to upgrade the customer's m300 with this enhancement.
Event or Problem Description
The customer reported that the telemetry monitor did not alarm for a short ventricular tachycardiac event that lasted 9 beats while the alarm was set to medium.The event was shown to be stored as an event at the ics.The arrythmia was witnessed by the staff present at the bedside.Additionally, the customer reported that patient information was missing, but did not confirm what patient information.No patient harm or adverse patient impact was reported.Since the reported malfunction, the device has correctly alarmed.
Additional Manufacturer Narrative
Updated evaluation.Several requests were made requesting additional information including the date of the event, device logs, and event full disclosure information.However, a response was received stating that no further information was available.The ecg strip for the event was not provided.As indicated in the m300/m300 plus instructions for use, the criteria for the algorithm to detect vtach is n or more consecutive premature ventricular contractions (pvcs) are detected, with a beat-to-beat rate greater than or equal to the vtach rate (n is the event count set in the count column of the arrhythmia setup table).Without the actual ecg strip for the event, we cannot recreate the event and root cause cannot be determined.
Event or Problem Description
The customer reported that the telemetry monitor did not alarm for a short ventricular tachycardiac event that lasted 9 beats while the alarm was set to medium.The event was shown to be stored as an event at the ics.The arrythmia was witnessed by the staff present at the bedside.Additionally, the customer reported that patient information was missing, but did not confirm what patient information.No patient harm or adverse patient impact was reported.After this, however, the customer stated there was a new incident for kvt and it was alerted.
Additional Manufacturer Narrative
Updated evaluation.Several requests were made requesting additional information including the date of the event, device logs, and event full disclosure information.However, a response was received stating that no further information was available.The ecg strip for the event was not provided.As indicated in the m300/m300 plus instructions for use, the criteria for the algorithm to detect vtach is n or more consecutive premature ventricular contractions (pvcs) are detected, with a beat-to-beat rate greater than or equal to the vtach rate (n is the event count set in the count column of the arrhythmia setup table).Without the actual ecg strip for the event, we cannot recreate the event and root cause cannot be determined.
Event or Problem Description
The customer reported that the telemetry monitor did not alarm for a short ventricular tachycardiac event that lasted 9 beats while the alarm was set to medium.The event was shown to be stored as an event at the ics.The arrythmia was witnessed by the staff present at the bedside.Additionally, the customer reported that patient information was missing, but did not confirm what patient information.No patient harm or adverse patient impact was reported.After this, however, the customer stated there was a new incident for kvt and it was alerted.

• 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: 19690424
• Report Number: 1220063-2024-00069
• Device Sequence Number: 7117907
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)231012(93)MS26800-53
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2025

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: MS26800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024; 06/13/2024; 06/13/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 02/07/2025; 04/03/2025; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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.; N/A.; N/A.; N/A.
• Patient Sex: Unknown