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

Catalog Number	MS33648
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported the infinity central station (ics) alerted that the m300+ telemetry monitor was offline.The ics read "discharge" without the patient being discharged.After a few minutes, the ics showed the m300+ online and recording worked immediately.Although the ics operated as intended and displayed an "offline" message alerting the user to the condition, the m300+ beside monitor discharged the patient.Reporting on near incident as patient data that is lost due an unintended discharge could impact patient treatment.In this case, there was no report of adverse patient impact.
Additional Manufacturer Narrative
The nurse readmitted the m300+ monitor back to the ics and the patient had to be admitted as a new patient.Per the device design, when the patient was readmitted, their historical data and trends were lost.Additional information regarding the state of the m300+ monitor at the time of the event, such as if it displayed a discharge message or if the patient¿s live data was still visible was requested but this information was not provided.The ics log files were reviewed and confirmed the reported event.However, the provided m300+ log files were reviewed, and it was found that they did not cover the reported event.The state of the m300+ monitor when it went offline was not able to be confirmed with the available log files, and therefore a root cause for the reported issue could not be determined.The instructions for use (ifu) for the infinity m300+ vg3.0/vg3.0.1 provide information regarding how to maintain logs for investigatory purposes.
Event or Problem Description
It was reported the infinity central station (ics) alerted that the m300+ telemetry monitor was offline.The ics read "discharge" without the patient being discharged.After a few minutes, the ics showed the m300+ online and recording worked immediately.Although the ics operated as intended and displayed an "offline" message alerting the user to the condition, the m300+ beside monitor discharged the patient.Reporting on near incident as patient data that is lost due an unintended discharge could impact patient treatment.In this case, there was no report of 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: 21799515
• Report Number: 1220063-2025-00028
• Device Sequence Number: 7740758
• Product Code: MHX
• UDI-Device Identifier: 04049098095730
• UDI-Public: (01)04049098095730(11)220105(93)MS33648-06
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MS33648
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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