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

Catalog Number	MS26800
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the infinity central station failed to alarm for ventricular tachycardia on (b)(6) and (b)(6).There was no report of patient injury or patient death.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
Draeger engineering found there were no log entries for ventricular tachycardia (vt) for the date of the reported event.However, there were three svr arrhythmia alarms found in the ecg-strips that were generated on the date of event ((b)(6) 2024).Requests were made for the arrhythmia settings, additional logs, along with additional information but they were not provided for this investigation.Therefore, the specific root for this issue could not be determined.The software versions on ics and the m300 are old.Various enhancements have been made to the new software versions regarding alarm detection and should be considered for future monitoring.This complaint is being closed and if in the future the proper logging and information is provided, a new complaint will be opened for the new information.There have been no additional reports of any errors from this customer's site.
Event or Problem Description
The customer reported that the infinity central station failed to alarm for ventricular tachycardia on march 5th and april 8th.There was no report of patient injury or patient death.

• 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 ; 9784097390
• MDR Report Key: 19153155
• Report Number: 1220063-2024-00045
• Device Sequence Number: 8501332
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)141001(93)MS26800-12
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2014
• 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: Other
• Patient Sex: Unknown