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	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted spacelabs healthcare to report that a xprezzon bedside monitor that shut down while monitoring a patient during a surgery.The custom requested a return authorization to return the faulty unit.At this time the device has not been received by spacelabs healthcare for further evaluation and repair.If additional information is made available, a follow up report will be submitted in accordance with 21 cfr 803.56.
Additional Manufacturer Narrative
Spacelabs healthcare received the unit and found the device had a faulty external video card.The technician also noted that the unit had an obsolete power supply board and backplane board.The faulty and obsolete parts were replaced.Following repair, the unit passed all final functional testing and was returned to the customer.The reported issue was due to a faulty external video card.Note regarding d4: added missing udi.

• 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: 23738747
• Report Number: 3010157426-2025-00226
• Device Sequence Number: 10150517
• Product Code: MHX
• UDI-Device Identifier: 10841522100550
• UDI-Public: (01)10841522100550(11)180214
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K120616
• 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,Followup
• Report Date (Section B): 01/21/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2018
• 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