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

Catalog Number	MS18500
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The customer reported that the ics system does not allow the staff to admit patients to the system, and that is the admission is successful, the patient information may disappear.The customer reported that the problem has been occurring since (b)(6) 2024, and did not report any patient injury or death.
Additional Manufacturer Narrative
Review of the log files and network trace provided indicated a possible issue with the downlink from the wireless access point (ap) to the m300 telemetry monitor and although requested, no further information was provided.Without a wireless signal communicating to a m300 the device, it would not be able communicate with the ics thus preventing an admittance to the central station.Though the issue is consistent with a site network issue and not a device malfunction, without further information from the site, the specific root cause cannot be determined.
Event or Problem Description
The customer reported that the ics system does not allow the staff to admit patients to the system, and that is the admission is successful, the patient information may disappear.The customer reported that the problem has been occurring since (b)(6) 2024, and did not report any patient injury or 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: 19359688
• Report Number: 1220063-2024-00062
• Device Sequence Number: 17767319
• Product Code: MHX
• UDI-Device Identifier: 04049098004190
• UDI-Public: (01)04049098004190(11)101116(93)MS18500-24
• 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: Consumer,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MS18500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2010
• 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