MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM SMART OCCLUDER; TUBE CLAMP

Model Number	QSOR
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On arrival as spectrum medical the unit appeared in good physical condition including level sensor ports.Testing with service sensor confirmed described fault; sensor is unresponsive when used in this unit.Programmed and replaced mcu pcb.Unit passed all pm tests afterwards.
Event or Problem Description
Annual pms occurred sometime between (b)(6) 2023.During pms, customer reported recent issue with level sensor.Spectrum fse tested level sensor and discovered it was faulty.Level sensor replaced with working on-site bonded inventory.During emergent case, new level sensor did not work.No further information is available about the failure.During troubleshooting steps, the level sensor was moved to the qvm2 and re-programmed in admin mode for move from occluder to qvm2.Level sensor worked as expected on qvm2.All other occluder functions working as expected.The level port on the occluder may not have been functioning during pms.

• Brand Name: QUANTUM SMART OCCLUDER
• Common Device Name: TUBE CLAMP
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 21263752
• Report Number: 3006073153-2025-00014
• Device Sequence Number: 15839291
• Product Code: DTQ
• UDI-Device Identifier: 05060434423443
• UDI-Public: 05060434423443
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K190282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: QSOR
• Device Catalogue Number: 51-000074-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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