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

Model Number	91496
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received at spacelabs healthcare and evaluated by a equipment service center technician.The device was tested and the reported problem was not verified.Additionally, no issues were found with the device.Cause of failure not established as no product failure was identified.
Event or Problem Description
The customer reported that while in use, the uvsl command module stopped monitoring patient parameters.There was no patient or user harm associated with this event.

• 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: 20858714
• Report Number: 3010157426-2024-00186
• Device Sequence Number: 8628146
• Product Code: DSI
• UDI-Device Identifier: 10841522106415
• UDI-Public: (01)10841522106415(11)230814
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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