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

Model Number	91393
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted spacelabs healthcare technical support to report that a xprezzon bedside monitor was frequently appearing offline at the xhibit central station and would stop working in the room.There was no patient or user harm associated with this event.The customer reported that the device would come back up, but would require the patient to be readmitted.Spacelabs technical support advised the customer that the symptoms indicate a possible power related issue and advised that have their biomed department evaluate the device.In a follow up call with the customer, the customer confirmed that no further issues were observed with the device and they were unaware of any additional information.Cause of failure could not be determined due to lack of information.If additional information is made available, a follow-up report will be submitted in accordance with 21 cfr 803.56.
Additional Manufacturer Narrative
Note regarding d4, udi field: only the gtin information for the reported device was provided as the serial number was not available.

• 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: 24318772
• Report Number: 3010157426-2026-00026
• Device Sequence Number: 17359167
• Product Code: MHX
• UDI-Device Identifier: 10841522131479
• UDI-Public: (01)10841522131479
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: 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: 01/13/2026
• Initial Report FDA Received Date: 02/11/2026
• 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