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

Model Number	MS26800
Medical Device Problem Codes	Failure to Transmit Record (1521); Loss of Data (2903)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a loss of full disclosure data was noticed on the infinity central station when the clinician tried to retrieve the patient data.A loss of full disclosure patient data could impact a clinician's ability to fully diagnose and or treat a patient.Draeger has started an investigation, a follow up will be provided when the investigation is complete.
Additional Manufacturer Narrative
The customer temporarily resolved the issue by re-initializing the icss, however, the issue occurred again.The customer reported that there was no adverse patient impact reported.The logs and network capture were reviewed by draeger.According to the draeger field service engineer (fse), the customer's engineer confirmed that there was a network port hardware failure on the hospital's standalone pendant unit.The fse replaced the pendant network ports and added new network points at the customer site.The draeger fse confirmed that the issue was resolved.There was no draeger monitor failure found.
Event or Problem Description
It was reported that a loss of full disclosure data was noticed on the infinity central station when the clinician tried to retrieve the patient data.A loss of full disclosure patient data could impact a clinician's ability to fully diagnose and or treat a patient.Draeger has started an investigation, a follow up will be provided when the investigation is complete.

• 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: 20965728
• Report Number: 1220063-2024-00136
• Device Sequence Number: 4033168
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)230526(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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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 Model 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: 12/03/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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