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

Model Number	96102
Medical Device Problem Codes	No Display/Image (1183); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction

• 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: adam moonshadow ; 35301 se center st; snoqualmie, WA 98065 ; +1(425)414-9737
• MDR Report Key: 50847374
• Report Number: 3010157426-2026-00142
• Device Sequence Number: 9508001
• Product Code: MHX
• UDI-Device Identifier: 10841522100246
• UDI-Public: (01)10841522100246
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• 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