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

Catalog Number	MS26800
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
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 that the (ics) infinity central station rebooted.When the (ics) reboots there is no patient monitoring at the central.In addition, it was reported that the associated bedside monitor (m300) did not monitor a patient during the ics reboot.A loss of monitoring at the central and bedside may delay patient treatment and care and has the potential for an adverse event to occur.
Event or Problem Description
It was reported that the (ics) infinity central station rebooted.When the (ics) reboots there is no patient monitoring at the central.In addition, it was reported that the associated bedside monitor (m300) did not monitor a patient during the ics reboot.A loss of monitoring at the central and bedside may delay patient treatment and care and has the potential for an adverse event to occur.
Additional Manufacturer Narrative
Several attempts were made by draeger to obtain additional facts regarding details of the reported issue, but only partial information was provided for this investigation.Without further information the root cause of the reboot failure cannot be determined.If more information should become available, a child record associated with this complaint will be opened for proper documentation.

• 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: 20978066
• Report Number: 1220063-2024-00139
• Device Sequence Number: 12856856
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)120723(93)MS26800-53
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 12/05/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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
• Patient Sex: Unknown