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

Model Number	91496
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 their spacelabs ultraview sl command module failed to detect that a patient was experiencing ventricular tachycardia.No patient or user harm was reported.The user was advised to swap the module for a known working module.Multiple unsuccessful attempts to follow up with the customer were made.If additional information is made available, a follow-up report will be submitted in accordance with 21 cfr 803.56.

• 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 central st; snoqualmie WA 98065
• Manufacturer Contact: whitney snyder ; 35301 se central st; snoqualmie, WA 98065
• MDR Report Key: 24397729
• Report Number: 3010157426-2026-00042
• Device Sequence Number: 21314028
• Product Code: DSI
• UDI-Device Identifier: 10841522106415
• UDI-Public: (01)10841522106415
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/19/2026
• 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