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

Model Number	91393
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while monitoring a patient an xprezzon bedside monitor shut down, would not boot back up, and would emit a constant beeping tone.The customer shipped the unit to spacelabs healthcare for depot repair.The unit was evaluated by an equipment service center technician who verified the reported failure.The issue was identified to be a result of a faulty video pcba.The unit was repaired by the technician and returned to the customer.The issue was due to a faulty video pcba.

• 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: 23824267
• Report Number: 3010157426-2025-00238
• Device Sequence Number: 9030852
• Product Code: MHX
• UDI-Device Identifier: 10841522100079
• UDI-Public: (01)10841522100079(11)240823
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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