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

Catalog Number	MS26800
Medical Device Problem Codes	Inappropriate Audible Prompt/Feedback (2280); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was no sp02 audio alarms at the central station, only visual alarms.The draeger technician confirmed this report.The technician found that the alarm settings on the central had been changed, and changed the settings.Once the settings were changed, the audible alarms immediately functioned as intended.It was reported that the customer's technical support and clinical had not been aware that this setting change was possible.The patient was reportedly in their room, and the customer states that there was no delay to patient treatment and no patient injury.There was no adverse patient impact or death reported.
Additional Manufacturer Narrative
A draeger field service engineer (fse) attended the site and conducted an on-site investigation.The fse confirmed that the m540s and other icss were alarming as expected.The fse compared the alarm patters of a functioning ics with the complaint device and was able to determine that the alarm tone pattern had been changed from the customers normal setting, infinity, to iec fast.After returning the alarm pattern to infinity, the alarms returned to function as the customer expected.The fse informed the sites tech support and supervisor of the alarm change.The fse stated that logs would not be available for review.It was reported in the complaint that there was no patient injury, and that the patient was in their bed being monitored without a delay in patient treatment.The instructions for use disclaim the ics alarm pattern tones, and how the users can change the alarm settings.Per the ifu, the alarm pattern can be changed on the alarms page under the system settings of the ics.On the iacs, this requires a clinical password.On the ics, the system setup clinical password can be enabled or disabled, depending on the customer configuration.Changing the ics alarm tone will change the alarm sequence.If a user changed these settings, other users not expecting the tone change may misinterpret or not understand the alarm behavior, and the iec fast alarm pattern behavior may be interpreted by users as "less urgent" than infinity alarm tones.Users are able to change the alarm pattern for each alarm priority.Changing ics alarm patterns could result in users thinking that the alarms are being "missed", while they alarm is being triggered.
Event or Problem Description
The customer reported that there was no sp02 audio alarms at the central station, only visual alarms.The draeger technician confirmed this report.The technician found that the alarm settings on the central had been changed, and changed the settings.Once the settings were changed, the audible alarms immediately functioned as intended.It was reported that the customer's technical support and clinical had not been aware that this setting change was possible.The patient was reportedly in their room, and the customer states that there was no delay to patient treatment and no patient injury.There was no adverse patient impact or death 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 ; 9784090504
• MDR Report Key: 20205099
• Report Number: 1220063-2024-00105
• Device Sequence Number: 6749930
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)190723(93)MS26800-36
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 08/14/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2019
• 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