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

Model Number	91393
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their xprezzon bedside monitor had crashed while in use.There was no patient or user harm associated with this event.The biomedical engineer had confirmed that the device was failing the power on self test for a dram issue prior to putting the unit into use, but they had put it into service regardless.The device has since been removed from service and will be returned to spacelabs healthcare for additional investigation.At this time the device has not been received.If additional information is made available, a follow up report will be submitted in accordance with 21 cfr 803.56.
Additional Manufacturer Narrative
The device was received by spacelabs health equipment service center.The repair technician reported that the issue was verified as the device would not power on due to a faulty cpu pcba.The device was repaired and returned to the customer.

• 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: 22476009
• Report Number: 3010157426-2025-00122
• Device Sequence Number: 18309936
• Product Code: MHX
• UDI-Device Identifier: 10841522100079
• UDI-Public: (01)10841522100079(11)191230
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 08/08/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2019
• 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