MAUDE Adverse Event Report: SPACELABS HEALTHCARE XPREZZON MONITOR; MULTIPARAMETER PATIENT MONITOR

Model Number	91393
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note regarding b4, udi field: only the gtin information for the reported device was provided as the serial number was not available.
Event or Problem Description
The customer provided an export of work orders that included alleged spacelabs healthcare product malfunctions.The following information was provided: spacelabs monitor is frozen.The biomed installed a loaner unit to resolve the immediate issue.The device was repaired on site by the biomed by replacing the display assembly.The customer was unable to provide additional information about this event.

• Brand Name: XPREZZON MONITOR
• Common Device Name: MULTIPARAMETER PATIENT 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: 23045728
• Report Number: 3010157426-2025-00173
• Device Sequence Number: 15870857
• Product Code: MHX
• UDI-Device Identifier: 10841522131479
• UDI-Public: (01)10841522131479
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112962
• 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): 09/12/2025

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: 91393
• 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: 08/15/2025
• Initial Report FDA Received Date: 09/12/2025
• 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