MAUDE Adverse Event Report: SPACELABS HEALTHCARE SPACELABS ULTRAVIEW SL COMMAND MODULE

Model Number	91496
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer contacted spacelabs healthcare to report that patient parameters were intermittently dropped while a ultraview command module was in use.There was no patient or user harm associated with this event.The customer's biomed evaluated the reported issue and found that the pins of the command module were bent and pushed in.The biomed readjusted the pins and confirmed that the issue was resolved.The cause of the reported issue was due to bent pins on the command module.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Common Device Name: SL COMMAND MODULE
• 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: 24284993
• Report Number: 3010157426-2026-00023
• Device Sequence Number: 9927430
• Product Code: DSI
• UDI-Device Identifier: 10841522106422
• UDI-Public: (01)10841522106422
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103142
• 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): 02/06/2026

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: 91496
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/06/2026
• 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