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

Model Number	QWS 15" HR STD
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation via case data confirmed customer selected the icon for close art clamp by mistake instead of entering data in viper manual entry menu - user would like to see a 2-step verification to disable level, pressure, bubble or close occlude from the dynamic display.Spectrum medical will look into whether this update is suitable.
Event or Problem Description
User reported event of unintentional closing of arterial occluder due to dynamic popup window on the display.While entering data on to the quantum workstation, the user reached the protected level, resulting in the dynamic display popping up.The pop up appeared exactly at the place of the manual entry, the icon for close art clamp was located, resulting in the user pressing for a closed art clamp and inturrupting the blood flow.The user was able to disable the occluder and continue the case without issue.There was no patient harm as a result of this.

• 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: 21949852
• Report Number: 3006073153-2025-00113
• Device Sequence Number: 8553974
• Product Code: DRY
• UDI-Device Identifier: 05060434422293
• UDI-Public: 05060434422293
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K163657
• 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
• Report Date (Section B): 05/02/2025

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: QWS 15" HR STD
• 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: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown