MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION; CENTRAL STATION REMOTE MONITOR

Model Number	96102
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer biomed contacted spacelabs healthcare technical support to report that while monitoring a telemetry patient on a xhibit central station (xcs), the display went blank.The biomed stated that the patient was moved to different central station to resume monitoring.There was no patient or user harm associated with the event.The biomed reported that they had attempted to swap the display and display port cable, however the issue persisted.A spacelabs healthcare field service engineer (fse) was paged to assist with further troubleshooting.The fse contacted the customer and walked the customer through troubleshooting the display.The customer reported after reseating the display port connections on both the display and xcs, the display returned.The customer called spacelabs healthcare back on (b)(6) 2025 and reported that the failure occurred again however the second instance the issue resolved on its own.The customer requested the device be evaluated and repaired as needed by the equipment service center.At this time the device has not been received.A follow up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
The device was received by spacelabs healthcare and evaluated by an equipment service center technician.The technician noted that the device had a lot of dust built up in the unit and the fan on the video card was not functional.Additionally, there was damage found on the main board and the front cover of the device.The customer was advised that due to the age of their device and part obsolescence their xhibit central station was no longer repairable, and that they would need to replace the device.The customer accepted the replacement and a new device was shipped to them for use.

• Brand Name: XHIBIT CENTRAL STATION
• Common Device Name: CENTRAL STATION REMOTE MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer (Section G): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer Contact: whitney snyder ; 35301 se center st; snoqualmie, WA 98065
• MDR Report Key: 23609591
• Report Number: 3010157426-2025-00223
• Device Sequence Number: 9249498
• Product Code: MHX
• UDI-Device Identifier: 10841522100345
• UDI-Public: (01)10841522100345(11)180611
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K122146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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 Model Number: 96102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Congenital Anomaly
• Patient Sex: Unknown