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

Catalog Number	MS20407
Medical Device Problem Code	Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there were several alarms but no events saved.All curves on the entire central monitoring unit are closed.Cannot make settings or close alarms (for example).The central monitoring unit still has a current display of parameters and was rebooted and currently works.There was no report of adverse event or patient harm.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
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 there were several alarms but no events saved.All curves on the entire central monitoring unit are closed.Cannot make settings or close alarms (for example).The central monitoring unit still has a current display of parameters and was rebooted and currently works.There was no report of adverse event or patient harm.
Additional Manufacturer Narrative
Attempts were made to clarify the exact issue the customer was reporting, what monitoring devices were in place during the event, the serial number of the infinity central station in question and any device logs to help identify the problem however no further information was available.The complaint states the infinity m500 with power as the suspected component, but it is unclear at this time if this device contributed to the root cause.The customer stated that a reboot of the central station worked to resolve the issue.The instructions for use for the iacs warns the iacs and m540 be used for primary diagnosis and the ics for patient viewing only.
Event or Problem Description
The customer reported that there were several alarms but no events saved.All curves on the entire central monitoring unit are closed.Cannot make settings or close alarms (for example).The central monitoring unit still has a current display of parameters and was rebooted and currently works.There was no report of adverse event or patient harm.

• 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: 19632840
• Report Number: 1220063-2024-00086
• Device Sequence Number: 7137597
• Product Code: MHX
• UDI-Device Identifier: 04049098054447
• UDI-Public: (01)04049098054447(11)221018(91)N/A(93)MS20407-21
• 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,Followup
• Report Date (Section B): 03/13/2025

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: MS20407
• 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; 06/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 03/13/2025; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown