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

Catalog Number	MS32504
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In this case, the issue was noted during the system installation.The infinity central station (ics) instructions for use (ifu) warns users that external speakers must always remain connected and powered on.Investigation confirmed that when the new edifier speakers [r19umkii] are used in analog mode, the speakers will not function if the analog cable is connected (into the speaker rear aux jack) before the speaker is powered up (initially or after loss of power).After a temporary loss of power, the analog connection must be reset by unplugging and then re-plugging the analog cable into the speaker rear aux jack.The issue occurs because the default speaker connection mode is usb.The usb connection is required for a power source even when used in analog mode.The mode is set to analog by connecting the analog cable into the speaker rear aux jack after the speaker is powered up.The speaker mode is indicated by the led next to the power button: the led is green for analog connection mode; the led is red for usb connection mode.Correction - the initial report was sent under mdr number 9611500-2023-00409 in error.The correct mdr for this submission is.
Event or Problem Description
It was reported that the users became aware that the external loudspeakers for the infinity central monitoring station will stay inactive after return of electrical power following an outage or disconnection.There was no patient involvement reported for the particular case.

• 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: 21018757
• Report Number: 1220063-2024-00140
• Device Sequence Number: 9133162
• Product Code: MHX
• UDI-Device Identifier: 04049098004190
• UDI-Public: 04049098004190
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/26/2024

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: MS32504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/26/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PR151781
• Patient Sequence Number: 1
• Patient Sex: Unknown