MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM WORKSTATION; MONITOR

Model Number	QWS12S
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion awaiting return of device and investigation.
Event or Problem Description
User reported that the quantum workstation touch screen failed to respond during a case.User noted pop-up of cardioplegia pump tile menu and could not exit the pop up or click anywhere else on the screen with response.Quantum workstation was immediately replaced with back up from other hlm so patient could be safely supported initiating bypass.Quantum workstation was hard rebooted outside of the or and ability to touchscreen returned.
Additional Manufacturer Narrative
Event logs were reviewed by spectrum medical service engineer.Logs show the customer selected to open the cpg blood pump dialog box.No "shadow clicked" message was logged to show the user tried to press away from the pop up to close the dynamic menu.With the pop-up was still open, the customer commanded the pump to zero flow, and requested a shutdown, shutting down the unit and disconnecting the mains.Customer confirmed after a hard reboot were performed, there have been no further issues with the qws.Spectrum to monitor the issue for any future occurrence's.Summary: reviewed event logs confirmed unit is functioning as expected logs did not show that the dynamic menu could not be closed or tried to be close.
Event or Problem Description
User reported that the quantum workstation touch screen failed to respond during a case.User noted pop-up of cardioplegia pump tile menu and could not exit the pop up or click anywhere else on the screen with response.Quantum workstation was immediately replaced with back up from other hlm so patient could be safely supported initiating bypass.Quantum workstation was hard rebooted outside of the or and ability to touchscreen returned.

• Brand Name: QUANTUM WORKSTATION
• Common Device Name: MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 21824954
• Report Number: 3006073153-2025-00103
• Device Sequence Number: 13105021
• Product Code: DRY
• UDI-Device Identifier: 05060434422293
• UDI-Public: 05060434422293
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: QWS12S
• Device Catalogue Number: 51-000093-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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