MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM; PHYSIOLOGIC MONITORING SYSTEM

Catalog Number	MS25520
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Codes	Idioventricular Rhythm (1923); Thromboembolism (2654)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they could only see short events in real-time curves, and that there is nothing in ics events.It was reported that this malfunction occurred on (b)(6), and that if there is a cvt or aivr, it is "saved during real-time curves" but it does not alarm or save.Additional information was requested to clarify the customer allegation.There was no report of a patient injury or death.
Event or Problem Description
The customer reported that they could only see short events in real-time curves, and that there is nothing in ics events.It was reported that this malfunction occurred on june 1st, and that if there is a cvt or aivr, it is "saved during real-time curves" but it does not alarm or save.Additional information was requested to clarify the customer allegation.There was no report of a patient injury or death.
Additional Manufacturer Narrative
Multiple attempts were made to the customer to obtain additional information regarding this event; however, no additional information was provided.Without logs or additional information, further investigation into the event is not possible and a root cause cannot be determined.

• Brand Name: INFINITY ACUTE CARE SYSTEM
• 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: 19558434
• Report Number: 1220063-2024-00067
• Device Sequence Number: 14665200
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)201019(93)MS25520-63
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: MS25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2020
• 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.
• Patient Sex: Unknown