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

Model Number	91389
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the qube mini would randomly power itself off and fails to produce the fail-safe alarm tone to notify staff of the power loss.The unit was removed from use and the biomed could not turn the unit back on.A depot repair request was created to repair the unit.At this time the device has not been received by spacelabs healthcare.If additional information is made available, a follow up report will be submitted in accordance with 21 cfr 803.56.
Additional Manufacturer Narrative
The device was evaluated by a spacelabs healthcare equipment service center (esc) for additional investigation.It was found that there was damage to the interconnect pcba and the wireless/touch pcba.After replacing the damaged parts, proper device operation was observed.The device was returned to the customer.

• 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: 22755867
• Report Number: 3010157426-2025-00140
• Device Sequence Number: 12940554
• Product Code: MHX
• UDI-Device Identifier: 10841522100239
• UDI-Public: (01)10841522100239(11)190218
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/04/2025

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: 91389
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2019
• 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