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

Model Number	91390
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer biomed reported that users notified him of an event that occurred around 19:30 est on (b)(6) 2025 bedside monitors in their emergency room department went blank and staff had to re-admit all patients.It was unknown how long the outage lasted and that there were no incidents that occurred related to the issue.The customer stated they were unaware of any power issues.When the biomed arrived on site, the dayshift staff stated that they had not observed any issues with devices and no faults were found while testing.The number of devices was unknown, but the biomed provided the details of one unit.The biomed stated they were just reporting the incident and no further information is known.If additional information is made available, a follow up report will be submitted in accordance with 21 cfr 803.56.

• 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: 23785942
• Report Number: 3010157426-2025-00236
• Device Sequence Number: 14881072
• Product Code: MHX
• UDI-Device Identifier: 10841522131455
• UDI-Public: (01)10841522131455
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 12/11/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/11/2025
• 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