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

Model Number	MS2680
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the alarm limits at the infinity central station (ics) could not be changed on the night of (b)(6) 2024.Reportedly, the alarm limits could not be adjusted to suit the patient, and the devices provided unnecessary and excessive alarming.This issue occurred for the telemetry units registered on the ics.One instance of the device alarming was when the heart rate limits could only be set to 20/min or 70/min as the lower limit for heart rate and 120/min or 200/min as the upper limit, with no other options.One patient had 500 bradycardia alarms in four hours, and the problem also caused alarms to ring continuously throughout the night for several patients.The customer reported that the "real alarms" were not as effectively detected among the "unnecessary" ringing, and that a bradycardia (22/min) was missed, but the nurses detected the issue.No adverse patient impact or death was reported.
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Additional Manufacturer Narrative
Diagnostic logs were sent for analysis, and no connection related problems were indicated for alarm conditions.There were some instances of slow connection indicating high network latency however, there were only a couple of instances of this during the timeframe for admitting of patients, not for the alarm limits screen.Furthermore, there were no ""remote control failed" error messages in the logs which, if present, would indicate a failure of the ics connection to the m300 devices.The clinical logs that were provided did not go back to the date and time of event which the customer stated to be overnight between (b)(6) 2024.Several requests were made for the correct clinical logs in addition to the ranges the customer experienced, if the ics screen, was grayed out at the time, a picture of the settings/display at the ics at the time of the event and if "bed control was enabled, however according to the (b)(6) 2025 email response, the logs and additional information was not available.The technical team was not able to reproduce this issue and clarification regarding limit adjustments possibly being available, but the ranges that were allowed not being correct or not what the customer expected, was not provided.Without further information an exact root cause into what the customer is stating cannot be determined.There have been no further issues reported after a reboot of the ics.If further information becomes available, a child record will be opened for proper documentation.
Event or Problem Description
The customer reported that the alarm limits at the infinity central station (ics) could not be changed on the night of sept 16 - 17th.Reportedly, the alarm limits could not be adjusted to suit the patient, and the devices provided unnecessary and excessive alarming.This issue occurred for the telemetry units registered on the ics.One instance of the device alarming was when the heart rate limits could only be set to 20/min or 70/min as the lower limit for heart rate and 120/min or 200/min as the upper limit, with no other options.One patient had 500 bradycardia alarms in four hours , and the problem also caused alarms to ring continuously throughout the night for several patients.The customer reported that the "real alarms" were not as effectively detected among the "unnecessary" ringing, and that a bradycardia (22/min) was missed, but the nurses detected the issue.No adverse patient impact or death was reported.

• 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: 20557866
• Report Number: 1220063-2024-00125
• Device Sequence Number: 8980023
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)200204(93)MS26800-38
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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 Model Number: MS2680
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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