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

Model Number	011-0262-00
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they had a xhibit central station display that had stopped working while being used to monitor patients.There was no patient or user harm associated with this event.The customer shipped the display to spacelabs healthcare and it was evaluated by an equipment service center technician.The device would not power on.Spacelabs does not manufacture this product; it will be sent to the oem for repair.A follow up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
The customer reported that they had a xhibit central station display that had stopped working while being used to monitor patients.There was no patient or user harm associated with this event.The customer shipped the display to spacelabs healthcare and it was evalauted by an equipment service center technician.The device would not power on.Spacelabs does not manufacture this product, it will be sent to the supplier for repair.A follow up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
The unit was was received, evaluated, and repaired by the oem.It was reported that the unit had a faulty power supply.The faulty part was replaced and the display was returned to the customer.B5 - minor correction was made to b5.

• 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: 22400245
• Report Number: 3010157426-2025-00112
• Device Sequence Number: 4939529
• Product Code: MHX
• UDI-Device Identifier: 10841522100536
• UDI-Public: (01)10841522100536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/09/2025

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: 011-0262-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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