MAUDE Adverse Event Report: Spacelabs Healthcare Xhibit Display; Central Station Remote Monitor Display

Model Number	011-0241-01
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction

• Brand Name: Xhibit Display
• Common Device Name: Central Station Remote Monitor Display
• 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: adam moonshadow ; 35301 se center st; snoqualmie, WA 98065 ; +1(425)414-9737
• MDR Report Key: 50890274
• Report Number: 3010157426-2026-00144
• Device Sequence Number: 10706293
• Product Code: MHX
• UDI-Device Identifier: 10841522100536
• UDI-Public: (01)10841522100536
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 011-0241-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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