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

Model Number	96102
Medical Device Problem Codes	Unexpected Shutdown (4019); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted spacelabs healthcare to report that while monitoring telemetry patients the xhibit central station (xcs) became unresponsive and they lost telemetry monitoring.There was no report of patient or user harm associated with the event.A spacelabs technical support representative walked the user through performing a hard reboot of the xcs.Following the reboot, the customer confirmed they were able to continue monitoring.However, the customer called back shortly after stating the device was acting erratically again.Technical support advised the customer reach out to their biomed to replace the xcs.Later in the morning, the biomed called spacelabs healthcare customer service to request repair of the xcs reporting that the device was overheating and randomly powering down.The customer shipped the device to spacelabs healthcare for depot repair.The device was evaluated by an equipment service center technician.The technician reported that the unit would power on, then shut down.The unit was found to have a faulty power supply and video card as well as a damaged fan on the motherboard.The technician also noted that the device had a lot of dust built up in the unit.The customer was advised that due to the age of their device and part obsolescence their xcs was no longer repairable, and that they would need to replace the device.The customer accepted exchanged unit in lieu of repair.

• 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 ; 4255594957
• MDR Report Key: 25116428
• Report Number: 3010157426-2026-00088
• Device Sequence Number: 18710120
• Product Code: MHX
• UDI-Device Identifier: 10841522100345
• UDI-Public: (01)10841522100345(11)170222
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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
• Date Returned to Manufacturer: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• 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