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

Catalog Number	MS26800
Medical Device Problem Codes	Telemetry Discrepancy (1629); Inaudible or Unclear Audible Prompt/Feedback (2283); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that ecg alarms/events are not recorded, and that patient data is missing.Additionally, the customer reported that, after updating the central telemetry system, the volume of alarms is much lower than before, and could not be changed, stating that users do not react to the new alarms.Additionally, the update changed the default settings for the alarm limits.The customer confirmed no adverse patient impact.
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 ecg alarms/events are not recorded, and that patient data is missing.Additionally, the customer reported that, after updating the central telemetry system, the volume of alarms is much lower than before, and could not be changed, stating that users do not react to the new alarms.Additionally, the update changed the default settings for the alarm limits.The customer confirmed no adverse patient impact.
Additional Manufacturer Narrative
Clarification was requested to determine the specific issue the customer states was occurring, all the systems that were affected and their serial and part numbers, as well as the event logs for the time of the event however, this information was not made available.For the description of event stating, "ecg alarms/events are not recorded.Patient data is missing." a similar issue has been investigated, and it was determined to be an issue with the infinity acute care system 7.1.1 configuration where it is possible an event may not be sent to the central station, for which there is a configuration upgrade in vg8.For the description of event for, "after updating the central telemetry system, the volume of alarms is much lower than before, which cannot be changed." no further information was provided.Without logs or additional information, further investigation into the event is not possible and a root cause cannot be determined.
Additional Manufacturer Narrative
Updated evaluation: for the description of event stating, "ecg alarms/events are not recorded.Patient data is missing." a similar issue has been investigated, and it was determined to be an issue with the infinity acute care system 7.1.1 configuration where it is possible an event may not be sent to the central station, for which there is a configuration upgrade in vg8.For the description of event for, "after updating the central telemetry system, the volume of alarms is much lower than before, which cannot be changed." further information was provided clarifying that when configuring the upgraded ics, based on discussion with the staff on duty at the time, draeger service changed the alarm sound from ¿infinity¿ to ¿iec¿ in an attempt improve the environment as there was a lot of dissatisfaction regarding the current alarm tone, and volume being too loud and noisy.However, not all the staff was informed of the change and the next day the next group of staff complained that they could miss alarms because the sound was too low.The alarm sound was changed back to ¿infinity¿ to resolve the issue.The staff being unable to change the alarm volume is normal behavior.Alarms can be muted, silenced, confirmed, and limits can be changed without a password.A change to the alarm tone and volume, requires a password.There was no device malfunction.
Event or Problem Description
The customer reported that ecg alarms/events are not recorded, and that patient data is missing.Additionally, the customer reported that, after updating the central telemetry system, the volume of alarms is much lower than before, and could not be changed, stating that users do not react to the new alarms.Additionally, the update changed the default settings for the alarm limits.The customer confirmed no 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: 19632475
• Report Number: 1220063-2024-00075
• Device Sequence Number: 15651915
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2025

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
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024; 06/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 02/05/2025; 04/22/2025
• 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.; N/A.
• Patient Sex: Unknown