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

Model Number	91390
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while monitoring a patient, a qube bedside monitor would intermittently shut itself off.There was no patient or user harm associated with this event.
Additional Manufacturer Narrative
Spacelabs healthcare technical support advised the caller to remove the product from use.The customer stated they would remove the device from use and send the unit in for repair at future date.At this time the customer has not opened a return request to ship the device back for depot repair.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: 21867967
• Report Number: 3010157426-2025-00073
• Device Sequence Number: 7888633
• Product Code: MHX
• UDI-Device Identifier: 10841522100550
• UDI-Public: (01)10841522100550
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/18/2025
• 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