MAUDE Adverse Event Report: SPACELABS HEALTHCARE SPACELABS HEALTHCARE QUBE COMPACT MONITOR; QUBE BEDSIDE

Model Number	91390
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note regarding b4, 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 reported that while monitoring patients, two xhibit central stations (xcs) would restart unexpectedly.The customer biomed performed troubleshooting and traced the issue to a qube bedside monitor.When the bedside monitor was added to a zone on the xcs, the xhibit software would crash and restart.Once the monitor was removed from use, no further issues have been reported.A product support specialist requested the monitor be shipped to spacelabs healthcare for further evaluation.At this time the device has not been received.A follow-up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
The device was received by the spacelabs healthcare equipment service center (esc) for evaluation.The esc technician evaluated the device where they were unable to verify the reported issue.The technician did find that the connector pcba was affecting the external nurse alert system, and the cpu pcba had some worn connectors.However, these would not contribute to the original reported issue.After the device was repaired, it was returned to the customer.The cause could not be determined as the reported issue was not duplicated.Correction made to d1 and d2.

• Brand Name: SPACELABS HEALTHCARE QUBE COMPACT MONITOR
• Common Device Name: QUBE BEDSIDE
• 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: 22959853
• Report Number: 3010157426-2025-00150
• Device Sequence Number: 20933901
• Product Code: MHX
• UDI-Device Identifier: 10841522131455
• UDI-Public: (01)10841522131455
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/04/2025

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: 91390
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2013
• 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