MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION DISPLAY; DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE

Model Number	011-0241-01
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer requested a depot service repair for a display that would blink and would not produce audio.The customer shipped the display to spacelabs healthcare for evaluation.The display was received and the reported problem was not verified.No malfunctions were identified.The device passed all testing and was returned to the customer.

• Brand Name: XHIBIT CENTRAL STATION DISPLAY
• Common Device Name: DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE
• 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: 21990929
• Report Number: 3010157426-2025-00085
• Device Sequence Number: 17221284
• Product Code: MHX
• UDI-Device Identifier: 10841522100536
• UDI-Public: (01)10841522100536(11)171115
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/08/2025

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: 011-0241-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• 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