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

Model Number	91390
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a cube bedside monitor shut down while in use.A spacelabs healthcare field service engineer (fse) went on site to attempt to reload the software of the device, however the device would not accept the software reload.The fse opened a rma to ship the unit in for further evaluation.At this time the unit 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 spacelabs healthcare equipment service center.The technian identified the unit had a faulty cpu pcba.The device was repaired, passed all final functional testing, and was returned ot the customer.The following corrections were also made to the previous mdr.D4 - added complete udi and h4 - added missing manufacture date.

• 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: 21990956
• Report Number: 3010157426-2025-00086
• Device Sequence Number: 4478026
• Product Code: MHX
• UDI-Device Identifier: 10841522100550
• UDI-Public: (01)10841522100550(11)220803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/08/2025

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: 04/10/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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