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

Model Number	96102
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a xhibit central station (xcs) was powering itself off after thirty minutes.A spacelabs healthcare field service engineer contacted the customer, a biomedical engineer, to assist with troubleshooting.The biomed found a broken heat sink and a faulty power supply assembly.The biomed replaced the faulty power supply, heat sink, and heat sink fan.After repair, it was found that the device would not boot up.A field service engineer was dispatched for additional investigation.The fse verified the issue and continued to reinstall the device software.After observing proper device operation, the device was returned to the customer 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: 22487802
• Report Number: 3010157426-2025-00125
• Device Sequence Number: 8016499
• Product Code: MHX
• UDI-Device Identifier: 10841522100345
• UDI-Public: (01)10841522100345(11)181010
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 07/11/2025

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
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2018
• 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
• Patient Sex: Unknown