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

Catalog Number	MS26800
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the telemetry patient information was not displayed at the central for hours after the patient was connected to the telemetry unit, and that no alarms and events were registered, and no analysis of the patient heart was able to be conducted during that time.After the users exchanged the telemetry unity, real time monitoring was restored.No adverse patient impact was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The customer reported that the telemetry patient information was not displayed at the central for hours after the patient was connected to the telemetry unit, and that no alarms and events were registered.After the users exchanged the telemetry unit, real time monitoring was restored.No adverse patient impact was reported.Several attempts were made to clarify the specific issue the customer states was occurring, how monitoring continued at the bedside and the event logs for the time of the event however, this information was not made available.Therefore, further investigation into the event is not possible and a root cause cannot be determined.Should further information be provided the complaint will be updated with the additional information.
Event or Problem Description
The customer reported that the telemetry patient information was not displayed at the central for hours after the patient was connected to the telemetry unit, and that no alarms and events were registered, and no analysis of the patient heart was able to be conducted during that time.After the users exchanged the telemetry unity, real time monitoring was restored.No adverse patient impact was reported.

• 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 ; 9784828529
• MDR Report Key: 19632470
• Report Number: 1220063-2024-00074
• Device Sequence Number: 8793844
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)150130(93)MS26800-15
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2015
• 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